Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 5:49 PM
Study NCT ID:
NCT01108835
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2010-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fannyko@cuhk.edu.hk', 'phone': '85226323133', 'title': 'Fanny Ko', 'organization': 'The Chinese University of Hong Kong'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.', 'otherNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Control arm with usual care', 'otherNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.', 'unitOfMeasure': 'hospital readmissions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Care Programme', 'description': 'Comprehensive care involving multidisciplinary input.\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '15.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'From contacting the patient/their family and hospital record retrieval.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lung Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.', 'unitOfMeasure': 'Percentage of Predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of predicted FEV1'}, {'type': 'SECONDARY', 'title': 'Exercise Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'spread': '61.2', 'groupId': 'OG000'}, {'value': '-22.5', 'spread': '71.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': 'Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Comprehensive Care', 'description': 'Comprehensive care\n\nComprehensive care programme: Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Control arm with usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age (years)', 'categories': [{'measurements': [{'value': '74.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '74.6', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '74.7', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'All subjects are recruited from Hong Kong.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-21', 'studyFirstSubmitDate': '2010-04-16', 'resultsFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-12', 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Readmission', 'timeFrame': '12 months', 'description': 'To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '12 months', 'description': 'Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.'}, {'measure': 'Mortality', 'timeFrame': '12 months', 'description': 'From contacting the patient/their family and hospital record retrieval.'}, {'measure': 'Lung Function', 'timeFrame': '12 months', 'description': 'Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.'}, {'measure': 'Exercise Capacity', 'timeFrame': '12 month', 'description': 'Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Comprehensive care'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '27471050', 'type': 'DERIVED', 'citation': 'Ko FW, Cheung NK, Rainer TH, Lum C, Wong I, Hui DS. Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Thorax. 2017 Feb;72(2):122-128. doi: 10.1136/thoraxjnl-2016-208396. Epub 2016 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'Objective: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study aims to assess whether a comprehensive care programme can decrease the rate of hospital admissions for COPD patients.', 'detailedDescription': "Design: A randomised controlled trial of patients discharged from hospital after an episode of acute exacerbation of COPD. Patients will be randomised to the intervention arm or usual care group.\n\nSetting: Tertiary University affiliated Hospital.\n\nInterventions:\n\nThe Intervention group will receive a comprehensive programme which involves inputs from doctors, respiratory nurses and physiotherapists, providing an individualized care plan for each subject. The components in the programme will include optimization of medications, specialist physician follow up, nursing support in education, and physiotherapist support for pulmonary rehabilitation. Patients in the intervention group will also receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and answer their queries. Patients will also be followed up in the respiratory clinic by respiratory specialist once every 3 months for 1 year.\n\nThe control group will be managed as the usual care. The discharging physician will determine the patients' medication and follow up as in normal practice.\n\nAll patients will be asked to return for assessments (spirometry, 6 minute walk test, questionnaires on the severity of dyspnoea and quality of life) at baseline and 12 months\n\nMain outcome measures: The primary endpoint is the hospital readmission rate and the secondary endpoints are the quality of life, mortality, lung function and exercise capacity of the patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study.\n* Patients with age over 40 years\n\nExclusion Criteria:\n\n* Patients with asthma\n* Patients unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01108835', 'briefTitle': 'A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'Resp/Ko/2010/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'comprehensive care programme', 'description': 'Comprehensive care involving multidisciplinary input.', 'interventionNames': ['Other: Comprehensive care programme']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control arm with usual care'}], 'interventions': [{'name': 'Comprehensive care programme', 'type': 'OTHER', 'description': 'Intervention group:\n\n* Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions\n* Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)\n* Respiratory physician assessment and optimization of treatment\n* Patients will also be taught about a personalized action plan by the physician and respiratory nurse.\n* Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries.', 'armGroupLabels': ['comprehensive care programme']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'David S Hui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Associate Professor', 'investigatorFullName': 'Fanny W.S. Ko', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}