Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT02068118
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fralsi-ctpublication@airliquide.com', 'phone': '33 (0) 1 39 07 62 86', 'title': 'Clinical Development Physician', 'organization': 'CDM e-Health'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release, can require changes to the communication and can embargo communications regarding trial results for a period that is less than or equal to 180 days from the time submitted to the sponsor for review. The modifications made by the sponsor cannot in any way affect the scientific value of the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There is no significant methodological limitation in this study.'}}, 'adverseEventsModule': {'timeFrame': 'During their study participation, patients were only examined once by the investigating cardiologists at the study centers, at the time of their enrolment and randomization. After this Inclusion Visit, patients were followed up via four telephone calls, conducted by clinical study technicians (at 15 days, 6, 12 and 18 months, all ±15 days).', 'description': 'Serious and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed in this study which did not involve any investigational medicinal product.\n\nDeaths and hospitalizations constituted the study outcome measures and efficacy criteria. Therefore, they were not considered a result from an Adverse Event and were not reported as Serious Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Care/Tele-cardiology', 'description': '* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.\n* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 455, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 90, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tele-cardiology Group/Tele-cardiology', 'description': '\\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.\n\n\\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 482, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 99, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of All Causes Deaths and (Unplanned) Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '1.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.23', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).\n\nDeaths that occurred during hospitalization with an overnight stay were counted as two events.', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.10', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).\n\nDeaths that occurred during hospitalization with an overnight stay were counted as two events.', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with New York Heart Association (NYHA) class III or IV at inclusion (N=460 patients)'}, {'type': 'PRIMARY', 'title': 'Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.89', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '1.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.92', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).\n\nDeaths that occurred during hospitalization with an overnight stay were counted as two events.', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with socially isolated status at inclusion (N=216 patients) defined as: either i) SF-36 Mental Health score \\<45; or ii) Mental Component Summary score \\<35; or iii) combination of Mental Health score \\<50 plus Mental Component Summary score \\<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications'}, {'type': 'SECONDARY', 'title': 'Time to First Unplanned Hospital Readmission or Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '238'}, {'value': '105', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '232'}]}]}], 'analyses': [{'pValue': '=0.68', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Time to first event compared using the log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'All Causes Deaths - Number of Patients Who Died From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Number of patients who died from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '390'}, {'value': '252', 'groupId': 'OG001', 'lowerLimit': '148', 'upperLimit': '369'}]}]}], 'analyses': [{'pValue': '=0.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Time to death from any cause compared using the log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to death from any cause in the subgroup of patients who died', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Unplanned Hospitalizations for Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '1.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.21', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for any cause (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.27', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).\n\nDeaths from cardiovascular cause that occurred during a hospitalization for cardiovascular cause with an overnight stay were counted as two events.', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of cardiovascular unplanned hospitalizations and deaths from cardiovascular cause (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Unplanned Hospitalizations for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.15', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for heart failure (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.04', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for heart failure (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with New York Heart Association (NYHA) class III or IV at inclusion (N=460 patients)'}, {'type': 'SECONDARY', 'title': 'Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.91', 'groupDescription': 'Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for heart failure (adjudicated events)', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with socially isolated status at inclusion (N=216 patients) defined as: either i) SF-36 Mental Health score \\<45; or ii) Mental Component Summary score \\<35; or iii) combination of Mental Health score \\<50 plus Mental Component Summary score \\<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications'}, {'type': 'SECONDARY', 'title': 'Time to First Unplanned Hospital Readmission for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '236'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '252'}]}]}], 'analyses': [{'pValue': '=0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.99', 'groupDescription': 'Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'title': 'Physical Functioning - 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning - 18 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '28.3', 'groupId': 'OG001'}]}]}, {'title': 'Role Physical - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '48.0', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '48.0', 'groupId': 'OG001'}]}]}, {'title': 'Role Physical - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '40.2', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '41.1', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '38.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '36.9', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '33.6', 'groupId': 'OG001'}]}]}, {'title': 'General Health - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '22.3', 'groupId': 'OG001'}]}]}, {'title': 'General Health - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Vitality - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Vitality - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '33.8', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '33.9', 'groupId': 'OG001'}]}]}, {'title': 'Role Emotional - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '45.7', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Role Emotional - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Summary - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Summary - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Summary - 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Summary - 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '4.61', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Physical Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with physical functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '6.21', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Role Physical score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role physical score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.46', 'ciLowerLimit': '0.59', 'ciUpperLimit': '8.33', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Bodily Pain score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with bodily pain score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.52', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '5.12', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA General Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with general health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.38', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '4.85', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Vitality score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with vitality score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.03', 'ciLowerLimit': '0.60', 'ciUpperLimit': '7.47', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Social Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with social functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '-2.79', 'ciUpperLimit': '4.81', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Role Emotional score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role emotional score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.26', 'ciLowerLimit': '0.16', 'ciUpperLimit': '4.37', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Mental Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with mental health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '2.28', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Physical Component Summary (PCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with PCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.31', 'pValueComment': 'Study group effect over time', 'groupDescription': 'ANCOVA Mental Component Summary (MCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with MCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and 12 months and between baseline and 18 months', 'description': 'Evolution of Quality of Life assessed using absolute changes from baseline of each dimension and both component summary scores of SF-36 questionnaire. Indeed, SF-36 questionnaire include 8 general dimensions and 2 composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). They are standardized to range between 0 and 100. Higher scores on all SF-36 scales indicate more favorable levels of functioning and less disability. Thus, higher Physical Functioning scores reflect higher physical functioning. Higher Role Physical scores reflect lower limitations due to physical problems. Higher Bodily Pain scores reflect less bodily pain. Higher General Health scores reflect higher general health perception. Higher Vitality scores reflect higher vitality. Higher Social Functioning scores reflect higher social functioning. Higher Role Emotional scores reflect lower limitations due to emotional problems. Higher Mental Health scores reflect better mental health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care/Tele-cardiology', 'description': '* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.\n* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.'}, {'id': 'OG001', 'title': 'Tele-cardiology/Tele-cardiology', 'description': '\\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.\n\n\\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Annualized number of unplanned hospitalizations for any cause according to investigators in patients hospitalized at least once during the extension period', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Period Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Died From Any Cause During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care/Tele-cardiology', 'description': '* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.\n* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.'}, {'id': 'OG001', 'title': 'Tele-cardiology/Tele-cardiology', 'description': '\\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.\n\n\\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Number of patients who died from any cause during the extension period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Period Set'}, {'type': 'SECONDARY', 'title': 'Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care/Tele-cardiology', 'description': '* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.\n* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.'}, {'id': 'OG001', 'title': 'Tele-cardiology/Tele-cardiology', 'description': '\\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.\n\n\\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Annualized number of unplanned hospitalizations from cardiovascular cause according to investigators in patients hospitalized at least once for cardiovascular cause during the extension period', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Period Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Died From Cardiovascular Cause During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care/Tele-cardiology', 'description': '* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.\n* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.'}, {'id': 'OG001', 'title': 'Tele-cardiology/Tele-cardiology', 'description': '\\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.\n\n\\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Number of patients who died from cardiovascular cause according to investigators during the extension period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Period Set'}, {'type': 'POST_HOC', 'title': 'Time to First Unplanned Hospital Readmission or Death From Any Cause in NYHA Class III or IV Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '191'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '158'}]}]}], 'analyses': [{'pValue': '=0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Time to first event compared using the log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'New York Heart Association (NYHA) class III or IV at inclusion patients with unplanned hospital readmission or death from any cause included in the Overall Number of Participants Analyzed'}, {'type': 'POST_HOC', 'title': 'Time to First Unplanned Hospital Readmission or Death From Any Cause in Socially Isolated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '240'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '277'}]}]}], 'analyses': [{'pValue': '=0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Time to first event compared using the log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Patients with socially isolated status at inclusion defined as: either i) SF-36 Mental Health score \\<45; or ii) Mental Component Summary score \\<35; or iii) combination of Mental Health score \\<50 plus Mental Component Summary score \\<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications and with unplanned hospital readmission or death from any cause included in the Overall Number of Participants Analyzed'"}, {'type': 'POST_HOC', 'title': 'Time to First Unplanned Hospital Readmission for Heart Failure in NYHA Class III or IV Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '182'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '183'}]}]}], 'analyses': [{'pValue': '=0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.95', 'groupDescription': 'Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'New York Heart Association (NYHA) class III or IV at inclusion patients with unplanned hospital readmission for heart failure included in the Overall Number of Participants Analyzed'}, {'type': 'POST_HOC', 'title': 'Time to First Unplanned Hospital Readmission for Heart Failure in Socially Isolated Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'OG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '231'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '318'}]}]}], 'analyses': [{'pValue': '=0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.98', 'groupDescription': 'Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Patients with socially isolated status at inclusion defined as: either i) SF-36 Mental Health score \\<45; or ii) Mental Component Summary score \\<35; or iii) combination of Mental Health score \\<50 plus Mental Component Summary score \\<40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications and with unplanned hospital readmission for heart failure included in the Overall Number of Participants Analyzed'"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care', 'description': '* Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.\n* Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.'}, {'id': 'FG001', 'title': 'Tele-cardiology Group', 'description': 'Device: Telecardiology Program\n\n\\- Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.\n\n\\- Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period.'}], 'periods': [{'title': '18-month Comparative Study Period', 'milestones': [{'type': 'STARTED', 'comment': '990 patients signed an informed consent, 937 returned home and started their ambulatory monitoring. These 937 patients constituted the "Intent to Treat" (ITT) population: 455 patients were in the Standard Care group and 482 patients in the Tele-cardiology Group.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '455'}, {'groupId': 'FG001', 'numSubjects': '482'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '177'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Heart transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Inclusion in another protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Hemiplegia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Alzheimer's disease", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Move', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hearing loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Standard Care/Tele-cardiology : Patients entered Period 2 if they wished and consented', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Tele-cardiology/Tele-cardiology : Patients entered Period 2 if they wished and consented', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Heart transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Wrong device use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between May 13, 2013 and June 22, 2016, 990 patients were enrolled at 38 French centers. Last patient completed 18-month comparative period on December 20, 2017. After this 18-month period, 20 patients entered the non-comparative extension period between June 1, 2017 and March 27, 2018. Last patient completed extension period on September 28, 2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'id': 'BG001', 'title': 'Tele-cardiology Group', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.7', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '70.0', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 60 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': '≥ 60 and < 80 years', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}, {'title': '≥ 80 years', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'BG000'}, {'value': '475', 'groupId': 'BG001'}, {'value': '927', 'groupId': 'BG002'}]}], 'categories': [{'title': 'I', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'II', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}, {'title': 'III', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "NYHA: New York Heart Association functional classification categories chronic heart failure patients in 4 stages based on how much they are limited during physical activity. Stage I corresponds to 'No limitation of physical activity', Stage II to 'Slight limitation of physical activity', Stage III to 'Marked limitation of physical activity' and Stage IV to 'Unable to carry on any physical activity without discomfort, symptoms of heart failure at rest", 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Cardiopathy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '935', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Ischemic', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}, {'title': 'Non Ischemic', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Heart failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '933', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Left', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'title': 'Right', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Global', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Left Ventricular Ejection Fraction (LVEF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '934', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.1', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Left ventricular ejection fraction refers to the percentage of blood that is pumped out of the filled left ventricle with each contraction of this ventricle. It is calculated on echocardiography mainly. It is the percentage corresponding to the ratio of heart stroke volume (which is the difference between end-diastolic volume and end-systolic volume) divided by end-diastolic volume.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Left Ventricular Ejection Fraction (LVEF), categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '934', 'groupId': 'BG002'}]}], 'categories': [{'title': '≤ 40%', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '560', 'groupId': 'BG002'}]}, {'title': '> 40% and ≤ 50%', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': '> 50%', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'BNP', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '484', 'groupId': 'BG000', 'lowerLimit': '301', 'upperLimit': '929'}, {'value': '510', 'groupId': 'BG001', 'lowerLimit': '303', 'upperLimit': '900'}, {'value': '501', 'groupId': 'BG002', 'lowerLimit': '303', 'upperLimit': '911'}]}]}], 'paramType': 'MEDIAN', 'description': 'BNP: B-type Natriuretic Peptide', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data and assay of either BNP or NT pro BNP for each participant.'}, {'title': 'NT-pro-BNP', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '534', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3277', 'groupId': 'BG000', 'lowerLimit': '1666', 'upperLimit': '6914'}, {'value': '3519', 'groupId': 'BG001', 'lowerLimit': '1778', 'upperLimit': '6553'}, {'value': '3379', 'groupId': 'BG002', 'lowerLimit': '1732', 'upperLimit': '6694'}]}]}], 'paramType': 'MEDIAN', 'description': 'N-Terminal-pro-B-type Natriuretic Peptide', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data and assay of either NT pro BNP or BNP for each participant.'}, {'title': 'Previous participation in an ETP', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '373', 'groupId': 'BG001'}, {'value': '714', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ETP= Educational Therapeutic Program', 'unitOfMeasure': 'Participants'}, {'title': 'Arterial hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dyslipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family History of Cardiovascular Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '382', 'groupId': 'BG000'}, {'value': '373', 'groupId': 'BG001'}, {'value': '755', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obesity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '333', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '675', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Obesity defined as Body Mass Index (BMI) ≥ 30.0 kg/m²', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '710', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary heart disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '473', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '630', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic renal disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '679', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Chronic Obstructive Pulmonary Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Implantable cardioverter-defibrillator', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '422', 'groupId': 'BG001'}, {'value': '817', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiac resynchronization therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '454', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Loop diuretics', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '417', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '864', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Beta-blockers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '746', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ACE inhibitors or ARBs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '699', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ACE: Angiotensin-Converting Enzyme; ARB: Angiotensin II Receptor Blocker', 'unitOfMeasure': 'Participants'}, {'title': 'Aldosterone antagonists', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ivabradine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '932', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '416', 'groupId': 'BG000'}, {'value': '456', 'groupId': 'BG001'}, {'value': '872', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Digoxin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '935', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '439', 'groupId': 'BG000'}, {'value': '453', 'groupId': 'BG001'}, {'value': '892', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Glomerular Filtration Rate (GFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '478', 'groupId': 'BG001'}, {'value': '933', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '25.1', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '25.5', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '25.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Glomerular Filtration Rate estimated using Modification of Diet in Renal Disease (MDRD) formula', 'unitOfMeasure': 'mL/min', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '79.3', 'spread': '18.2', 'groupId': 'BG001'}, {'value': '78.3', 'spread': '18.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '27.4', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Supine systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '118.9', 'spread': '19.3', 'groupId': 'BG000'}, {'value': '119.6', 'spread': '19.9', 'groupId': 'BG001'}, {'value': '119.3', 'spread': '19.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Supine diastolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '937', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.5', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '69.9', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '69.7', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Supine pulse rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '73.7', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '73.2', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats/min', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Difference from the overall number of baseline participants due to missing data.'}], 'populationDescription': 'ITT population included all study patients randomized once, who left the hospital alive and continued their study participation after their home return and who were not included in the 2 study centers where investigators withdrew their participation.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-06', 'size': 834655, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-23T11:24', 'hasProtocol': True}, {'date': '2019-03-21', 'size': 696473, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-23T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 990}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2014-02-17', 'resultsFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-28', 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of All Causes Deaths and (Unplanned) Hospitalizations', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)'}, {'measure': 'Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)'}, {'measure': 'Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)'}], 'secondaryOutcomes': [{'measure': 'Time to First Unplanned Hospital Readmission or Death From Any Cause', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned'}, {'measure': 'All Causes Deaths - Number of Patients Who Died From Any Cause', 'timeFrame': '18 months', 'description': 'Number of patients who died from any cause'}, {'measure': 'Time to Death From Any Cause', 'timeFrame': '18 months', 'description': 'Time to death from any cause in the subgroup of patients who died'}, {'measure': 'Number of Unplanned Hospitalizations for Any Cause', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for any cause (adjudicated events)'}, {'measure': 'Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause', 'timeFrame': '18 months', 'description': 'Composite morbidity-mortality criterion combining the number of cardiovascular unplanned hospitalizations and deaths from cardiovascular cause (adjudicated events)'}, {'measure': 'Number of Unplanned Hospitalizations for Heart Failure', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for heart failure (adjudicated events)'}, {'measure': 'Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for heart failure (adjudicated events)'}, {'measure': 'Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients', 'timeFrame': '18 months', 'description': 'Number of unplanned hospitalizations for heart failure (adjudicated events)'}, {'measure': 'Time to First Unplanned Hospital Readmission for Heart Failure', 'timeFrame': '18 months', 'description': 'Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned'}, {'measure': 'Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores', 'timeFrame': 'Between baseline and 12 months and between baseline and 18 months', 'description': 'Evolution of Quality of Life assessed using absolute changes from baseline of each dimension and both component summary scores of SF-36 questionnaire. Indeed, SF-36 questionnaire include 8 general dimensions and 2 composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). They are standardized to range between 0 and 100. Higher scores on all SF-36 scales indicate more favorable levels of functioning and less disability. Thus, higher Physical Functioning scores reflect higher physical functioning. Higher Role Physical scores reflect lower limitations due to physical problems. Higher Bodily Pain scores reflect less bodily pain. Higher General Health scores reflect higher general health perception. Higher Vitality scores reflect higher vitality. Higher Social Functioning scores reflect higher social functioning. Higher Role Emotional scores reflect lower limitations due to emotional problems. Higher Mental Health scores reflect better mental health.'}, {'measure': 'Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Annualized number of unplanned hospitalizations for any cause according to investigators in patients hospitalized at least once during the extension period'}, {'measure': 'Number of Patients Who Died From Any Cause During the Extension Period', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Number of patients who died from any cause during the extension period'}, {'measure': 'Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Annualized number of unplanned hospitalizations from cardiovascular cause according to investigators in patients hospitalized at least once for cardiovascular cause during the extension period'}, {'measure': 'Number of Patients Who Died From Cardiovascular Cause During the Extension Period', 'timeFrame': 'Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months)', 'description': 'Number of patients who died from cardiovascular cause according to investigators during the extension period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['E health', 'Telemonitoring', 'Prevention', 'Heart Failure', 'Cordiva', 'Telecardiology Program', 'Remote Patient Management', 'Education'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '32438483', 'type': 'RESULT', 'citation': 'Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartiere L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Targeted population: Patients with heart failure causing hospitalization during the last twelve months.\n\nHypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required.\n\nMain goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.', 'detailedDescription': 'COMPARATIVE STUDY:\n\nComparative study of patients with chronic heart failure, randomized ratio (1:1), with two study arms (telecardiology vs usual care). French multicenter study.\n\nThe planned enrolment is 990 patients in a total period of 3.5 years. This study will involve an enrolment visit, managed by the recruiting investigator cardiologist, then four telephone contacts by Clinical Studies Technicians (CST). The purpose of the CST telephone contacts is to record the study data, and this will be occur for both study arms. Throughout the study, the patients in the telecardiology study arm will have regular contact with the Cordiva nurses for the management of their chronic heart failure, through telemonitoring and coaching. There is no planned hospitalization for the study.\n\nPatients in the control group will receive the usual care: After enrolment, they will return home and will subsequently have regular visits to their General Practitioner (GP) or referring cardiologist.\n\nPatients in the telecardiology group will receive the necessary monitoring equipment in their home in the week following their enrolment visit. This equipment includes a connected electronic scale and a questionnaire box. This questionnaire is designed to evaluate the evolution of patient symptoms.\n\nDuring the presentation of the study to the patient before study inclusion, the investigator will inform the patient about the use of the equipment.\n\nThe material provided is "self installable" but if the patient asks for help, the equipment will be installed at the patient\'s home by a private nurse, who also will check that the patient knows how to use the equipment.\n\nEach patient will respond daily to 8 yes/no questions:\n\n* Did you have more breathing issues last night than the previous night?\n* Did you need an extra pillow for better breathing last night?\n* Do you cough more than usual?\n* Are your legs are more swollen than usual?\n* Do you feel yourself more tired than usual?\n* Have you had or do you have a fever above 38.5 °C?\n* Have you felt or do you feel palpitations?\n* Do you find that your physical activity is more limited today than the previous days?\n\nPatients should simply answer yes or no to all of these questions through the questionnaire box.\n\nThe self-monitoring parameters (weight and questionnaire answers) will be remotely transmitted via standard phone lines (wired, 3G or GPRS) to the secured servers.\n\nThese data will be analyzed automatically by an expert system that will generate an alert in case of abnormal values. The objective is to anticipate possible acute cardiac failure.\n\nThe specialized nurses from the Cordiva center will manage those alerts during working hours and will contact the patient to validate with him the relevance of the alert. If the clinical reality of the alert is confirmed, the nurse will advise the patient to contact his GP or referring cardiologist. In parallel to the nurse advising the patient, the referring physician will receive an alert report including the weight values and the symptoms which triggered this alert. Then, he can then take any action he considers appropriate.\n\nA binder will be sent to the patients. This will contain various information related to the management of their heart failure: heart physiology, symptoms, treatments, diet, physical activity...\n\nThe purpose of this binder is to support the discussion between the Cordiva nurses and the patient.\n\nUpon receipt and installation of the equipment in the patient\'s home, the nurses will arrange a first telephone interview, which will last approximately 45 minutes. The nurses will first introduce the team and the overall clinical approach, and will have a discussion with the patient to better understand the patient (anamnesis, treatment, psycho-social profile, smoking, alcohol use, physical activity, and so on).\n\nAfter this call, patient and nurse will together determine together the date for the next phone call date.\n\nOn a regular basis (for example every three weeks), a Cordiva nurse will call the patient to check the current status of his disease and its treatment, and to assist him in the management of his disease on a daily basis (compliance, physical activity, nutrition, illness experience... ) . This call will last approx. 15 minutes, however, the duration of the call is not limited, but is defined according to the needs of the patient.\n\nAt the end of each call, the nurse will define with the patient educational goals (disease knowledge, treatments, recognizing acute episodes symptoms, learning better health habits, practise regular physical activity).\n\nCordiva center is also available for patient\'s inbound calls. In this way, patients will be able to easily call the center during working hours, and discuss with a specialized Cordiva nurse. This line is not an emergency line and does not replace the 112, which remains the only accredited contact in case of emergencies.\n\nIn case of temporary travel of the patient away from home (i.e. for holidays), the patient can take the box and scale with him. This material is provided with GPRS SIM card, so the connection will be maintained. The patient may also provide an alternative phone number for the calls with the nurses.\n\nThe patient\'s GP will be involved in this outpatient care from the beginning of the study. Indeed, data collected through the connected boxes and scales will be displayed in dedicated reports sent to the GP. These reports will be transmitted every 2 months. These reports will also be sent to the referring cardiologist if requested.\n\nMoreover, in case of validated alerts, the referring physician will have access to a weight and symptoms report, allowing him to take any action he thinks appropriate.\n\nABOUT CORDIVA CENTER: The center has a team of specialized and graduated nurses in heart failure management and in therapeutic education, due to the dedicated training they have received. Indeed, many studies in the multidisciplinary care of heart failure patients have demonstrated the key role of nurses, acting as bridge between patients and health professionals.\n\nThe nurses take care of patient compliance based on the referring cardiologist or general practitioner instructions, and monitor patient clinical parameters (weight and symptoms). The nurses use a software based interviews guide. Patient objectives are defined based on information regarding certain factors (health status, clinical signs, drugs), and this information will be collected by the nurses into a computerized database. This information is requested in strict patient accompanying perspective and therefore do not appear in the study results.\n\nThe two data sets (data collected by nurses for patient management on one hand, and data collected by CST for the study on another hand) will never be connected and only study data from CST will be used to assess study criteria.\n\nTo evaluate patient knowledge and needs, the nurses use active listening (open questions, paraphrasing, empathy and positive reinforcement). These techniques help them to customize information and messages and reinforce personalized care. Cordiva center nurses benefit from specialized training in motivational interviewing. They have also received dedicated training in cardiology and heart failure, "mental state" of heart failure patients, communication and patient education.\n\nCoherence of this informative approach is guaranteed on one hand because of the tools available for the nurses (binder, interview guide), and on the other hand because of the center organization itself: monitoring of patients insured by team of nurses, weekly debrief of recorded calls…\n\nEXTENSION PERIOD:\n\nThe extension period will be conducted on an open, non-comparative basis. The aim of the extension period is to allow patients who wish to do so to follow the telemonitoring program until its marketing, regardless of the randomization group on initial inclusion in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 years or older\n* Men or women patient with heart failure having been hospitalized for cardiac decompensation during the last 12 months.\n* Patient with access to a wireline telephone service or GPRS network.\n* The patient is willing and able to sign an informed written consent\n* Patient is insured under the social security system\n\nExclusion Criteria:\n\n* No available echocardiographic evaluation.\n* BNP lower than 100pg/ml or NT-proBNP lower than 300pg/ml\n* A prognosis of a life span of less than 12 months (apart from heart failure)\n* Dialysis patients\n* Heart transplant or cardiac assist devices\n* Patients involved in inotropic treatment\n* Patient doesn't have the necessary autonomy to use the equipment\n* Patient enrolled in another clinical trial\n* A pregnant or nursing woman, or patient of reproductive age who doesn't use contraceptives\n* Patients under tutorship, curatorship or judicial protection\n\nInclusion Criteria in the extension period:\n\nParticipation in the open extension period is only offered to patients who participated in the comparative period of the study, did not withdraw prematurely from the latter and gave their free informed written consent to participate to the extension period."}, 'identificationModule': {'nctId': 'NCT02068118', 'acronym': 'OSICAT', 'briefTitle': 'Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology', 'organization': {'class': 'INDUSTRY', 'fullName': 'CDM e-Health'}, 'officialTitle': 'Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)', 'orgStudyIdInfo': {'id': '2012-A01672-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists'}, {'type': 'EXPERIMENTAL', 'label': 'Tele-cardiology group', 'description': 'Telecardiology Program', 'interventionNames': ['Device: Telecardiology program']}], 'interventions': [{'name': 'Telecardiology program', 'type': 'DEVICE', 'description': 'The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses.\n\nAutomatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure.', 'armGroupLabels': ['Tele-cardiology group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Béziers', 'state': 'Languedoc-Rousillon', 'country': 'France', 'facility': 'Cabinet de Cardiologie - Pôle médical spécialisé', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '34500', 'city': 'Béziers', 'state': 'Languedoc-Roussillon', 'country': 'France', 'facility': 'Centre Hospitalier de Béziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '87500', 'city': 'Saint-Yrieix-la-Perche', 'state': 'Limousin', 'country': 'France', 'facility': 'Cabinet libéral', 'geoPoint': {'lat': 45.5145, 'lon': 1.20329}}, {'zip': '31600', 'city': 'Muret', 'state': 'Midi-pyrenées', 'country': 'France', 'facility': 'Cabinet libéral de Cardiologie du Muret', 'geoPoint': {'lat': 43.45998, 'lon': 1.32541}}, {'zip': '32008', 'city': 'Auch', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': "Centre Hospitalier Général d'Auch", 'geoPoint': {'lat': 43.64561, 'lon': 0.58856}}, {'zip': '82500', 'city': 'Beaumont-de-Lomagne', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Centre de réadaptation cardiovasculaire Midi-Gascogne', 'geoPoint': {'lat': 43.88303, 'lon': 0.98768}}, {'zip': '46000', 'city': 'Cahors', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Centre Hospitalier de Cahors', 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}, {'zip': '81108', 'city': 'Castres', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Castres-Mazamet', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'zip': '31700', 'city': 'Cornebarrieu', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'zip': '31240', 'city': "L'Union", 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': "Clinique de l'Union et du Vaurais", 'geoPoint': {'lat': 43.66042, 'lon': 1.48264}}, {'zip': '82000', 'city': 'Montauban', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Clinique du Pont de Chaume', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '12027', 'city': 'Rodez', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Centre Hospitalier de Rodez', 'geoPoint': {'lat': 44.35258, 'lon': 2.57338}}, {'zip': '09000', 'city': 'Saint-Jean-de-Verges', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': "Centre Hospitalier Intercommunal du Val d'Ariège", 'geoPoint': {'lat': 43.01377, 'lon': 1.61079}}, {'zip': '65000', 'city': 'Tarbes', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': "Polyclinique de l'Ormeau", 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Toulouse - Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31076', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31076', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': 'Hôpital Joseph Ducuing', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Amiens de Picardie", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '84090', 'city': 'Avignon', 'country': 'France', 'facility': "Centre Hospitalier d'Avignon - Hospital Henri Duffaut", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '20604', 'city': 'Bastia', 'country': 'France', 'facility': 'Centre Hospitalier de Bastia', 'geoPoint': {'lat': 42.70219, 'lon': 9.45123}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Bordeaux - Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Lyon - Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire François Mitterrand - Cardiologie 2 : Rythmologie et Insuffisance Cardiaque', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire François Mitterrand - Cardiologie Générale', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '83418', 'city': 'Hyères', 'country': 'France', 'facility': 'Hôpital Léon Bérard', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Grenoble - Hôpital Antoine Michallon', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Marseille - Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nice - Hôpital Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30000', 'city': 'Nîmes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '64420', 'city': 'Pau', 'country': 'France', 'facility': 'Centre Hospitalier de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Bordeaux - Hôpital Haut Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'facility': 'Centre Hospitalier de Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '83056', 'city': 'Toulon', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '97200', 'city': 'Fort-de-France', 'country': 'Martinique', 'facility': 'Centre Hospitalier Universitaire de Martinique', 'geoPoint': {'lat': 14.60365, 'lon': -61.07418}}], 'overallOfficials': [{'name': 'Michel GALINIER, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rangueil University Hospital - Toulouse'}, {'name': 'Atul PATHAK, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Pasteur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CDM e-Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}