Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT00282334
Status:
COMPLETED
Last Update Posted:
2011-08-01
First Post:
2006-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparison of Telemedical and Conventional Antihypertensive Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linemads@rm.dk', 'phone': '+45 99125421', 'title': 'Line Bille Madsen', 'organization': 'Dept. of Medical Research, Holstebro Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Technical difficulties with telemedical equipment,referral bias,unblinded study'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Conventional Blood Pressure Monitoring', 'otherNumAtRisk': 123, 'otherNumAffected': 0, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Telemonitoring of Home Blood Press', 'otherNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Number of Patients Who Reached Target Blood Pressure', 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Blood Pressure Monitoring'}, {'id': 'OG001', 'title': 'Telemonitoring of Home Blood Press'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.9', 'spread': '14.8', 'groupId': 'OG000', 'lowerLimit': '-6.1', 'upperLimit': '1.5'}, {'value': '-9.6', 'spread': '14.7', 'groupId': 'OG001', 'lowerLimit': '-6.1', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telemonitoring', 'description': 'Telemonitoring of home blood pressure'}, {'id': 'FG001', 'title': 'Conventional', 'description': 'Conventional blood pressure monitoring'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Blood Pressure Monitoring'}, {'id': 'BG001', 'title': 'Telemonitoring of Home Blood Press'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '56.7', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-29', 'studyFirstSubmitDate': '2006-01-24', 'resultsFirstSubmitDate': '2010-02-18', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-27', 'studyFirstPostDateStruct': {'date': '2006-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Number of Patients Who Reached Target Blood Pressure', 'timeFrame': '6 months'}, {'measure': 'Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months', 'timeFrame': 'baseline and 6 months', 'description': 'Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Blood pressure', 'Quality of life', 'Cost-effectiveness'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '21105759', 'type': 'DERIVED', 'citation': 'Madsen LB, Christiansen T, Kirkegaard P, Pedersen EB. Economic evaluation of home blood pressure telemonitoring: a randomized controlled trial. Blood Press. 2011 Apr;20(2):117-25. doi: 10.3109/08037051.2010.532306. Epub 2010 Nov 24.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to compare telemedical antihypertensive treatment based on home blood pressure monitoring and conventional antihypertensive treatment based on monitoring of blood pressure in the doctor's office.\n\nWe want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 - 80 years\n* office blood pressure \\> 150/95 mmHg or systolic blood pressure \\>150 mmHg and diastolic blood pressure \\< 90 mmHg\n\nExclusion Criteria:\n\n* not able to perform home blood pressure measurements\n* low compliance\n* abuse of alcohol/ medicine\n* unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT00282334', 'briefTitle': 'A Comparison of Telemedical and Conventional Antihypertensive Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'A Comparison of Telemedical and Conventional Antihypertensive Treatment', 'orgStudyIdInfo': {'id': 'MED.RES.2004.01.LBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home blood pressure telemonitoring', 'interventionNames': ['Device: Telemedical blood pressure monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional blood pressure monitoring'}], 'interventions': [{'name': 'Telemedical blood pressure monitoring', 'type': 'DEVICE', 'description': 'Measurement of home blood pressure, three times per week for three months and once a week for three months.', 'armGroupLabels': ['Home blood pressure telemonitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Dept. of Medical Research, Holstebro Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Line B Madsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark'}, {'name': 'Erling B Pedersen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Erling Bjerregaard Pedersen', 'oldOrganization': 'Dept. of Medical Research, Holstebro Hospital'}}}}