Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT00877318
Status:
TERMINATED
Last Update Posted:
2016-03-18
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Rehabilitation of Heart Failure Patients by Telemedicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-17', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization', 'timeFrame': '3 months'}, {'measure': 'BNP', 'timeFrame': '3 months'}, {'measure': '% patient with a BNP < 300 pg/ml', 'timeFrame': '3 months'}, {'measure': 'Medical treatment by ACE inhibitor (in % of target dose)', 'timeFrame': '3 months'}, {'measure': 'Ejection fraction of left ventricle', 'timeFrame': '3 months'}, {'measure': 'Disease knowledge questionnaire', 'timeFrame': '3 months'}, {'measure': 'Life quality questionnaire (Minnesota)', 'timeFrame': '3 months'}, {'measure': 'Beck questionnaire', 'timeFrame': '3 months'}, {'measure': 'Day number at hospital', 'timeFrame': '3 months'}, {'measure': 'Number of medical consultation', 'timeFrame': '3 months'}, {'measure': 'Pharmaco-economic analysis', 'timeFrame': '3 months'}, {'measure': 'Total mortality', 'timeFrame': '3 months'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a dysfunction of left ventricle with ejection fraction of left ventricle \\< 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.\n\nExclusion Criteria:\n\n* Patient non authorized to follow an effort training\n* Therapeutic education impossible\n* Pregnant woman or breast-feeding\n* No assent\n* Incapacity to use the terminal\n* Minor patient or under supervision'}, 'identificationModule': {'nctId': 'NCT00877318', 'acronym': 'READ', 'briefTitle': 'Cardiac Rehabilitation of Heart Failure Patients by Telemedicine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.', 'orgStudyIdInfo': {'id': 'B80908-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Program of cardiac rehabilitation introduced in complete hospitalization pursued in day hospital during 3 months'}, {'type': 'EXPERIMENTAL', 'label': 'telemedicine', 'description': 'Program of cardiac rehabilitation introduced in complete hospitalization pursued at home via a terminal during 3 months', 'interventionNames': ['Device: SCAD information system']}], 'interventions': [{'name': 'SCAD information system', 'type': 'DEVICE', 'description': 'Cardiac rehabilitation at home by telemedicine', 'armGroupLabels': ['telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14113', 'city': 'Cricquebœuf', 'country': 'France', 'facility': 'Centre Hospitalier de la Côte Fleurie', 'geoPoint': {'lat': 49.40152, 'lon': 0.14683}}, {'city': "Saint-Martin-d'Aubigny", 'country': 'France', 'facility': 'William Harvey Center', 'geoPoint': {'lat': 49.16512, 'lon': -1.34976}}], 'overallOfficials': [{'name': 'Annette Belin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}, {'name': 'Rémi Sabatier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}