Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT00878202
Status:
TERMINATED
Last Update Posted:
2013-02-20
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Education by Telemedicine in Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-12-14', 'releaseDate': '2017-07-20'}], 'estimatedResultsFirstSubmitDate': '2017-07-20'}}, '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': 100}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-19', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hospitalization days for heart failure', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '12 months'}, {'measure': 'Total mortality', 'timeFrame': '12 months'}, {'measure': 'Rate of hospitalization for heart failure', 'timeFrame': '12 months'}, {'measure': 'Median of time up to mortality or hospitalization for heart failure', 'timeFrame': '12 months'}, {'measure': 'Number of medical consultation', 'timeFrame': '12 months'}, {'measure': 'Pharmaco-economic analysis', 'timeFrame': '12 months'}, {'measure': 'Disease knowledge questionnaire', 'timeFrame': '12 months'}, {'measure': 'Quality of life questionnaire ( Minnesota)', 'timeFrame': '12 months'}, {'measure': 'BNP', 'timeFrame': '12 months'}, {'measure': 'Six minutes walk test', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 65 years old hospitalized for acute heart failure\n* Left ventricle systolic Dysfunction with ejection fraction \\< 45 %, documented in the previous 6 months\n* And at least one of the following criteria:\n\nBNP before discharge from hospital \\> 350 pg/ml / EF \\< 35 % / Hospitalization for acute heart failure informed in the previous 6 months\n\nExclusion Criteria:\n\n* NYHA 4 at hospital discharge\n* Planned cardiac surgery or coronary revascularization\n* Hospitalization for ST-elevation acute coronary syndrome\n* Depressive syndrome with score \\> 20 at geriatric depression scale\n* Therapeutic education impossible\n* Technical problems with the device\n* Limited autonomy for device use\n* Patient not living in Basse-Normandie\n* Ongoing participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00878202', 'acronym': 'SEDIC', 'briefTitle': 'Therapeutic Education by Telemedicine in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.', 'orgStudyIdInfo': {'id': 'B80909-60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Optimal medical treatment of Heart failure and therapeutic education'}, {'type': 'EXPERIMENTAL', 'label': 'Telemedicine', 'description': 'Optimal medical treatment of heart failure disease and therapeutic education', 'interventionNames': ['Device: SCAD information system']}], 'interventions': [{'name': 'SCAD information system', 'type': 'DEVICE', 'description': 'Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months', 'armGroupLabels': ['Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61000', 'city': 'Alençon', 'country': 'France', 'facility': 'Alençon-Mamers Hospital', 'geoPoint': {'lat': 48.43476, 'lon': 0.09311}}, {'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Cherbourg', 'country': 'France', 'facility': 'Cherbourg Hospital', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'city': 'Flers', 'country': 'France', 'facility': 'Flers Hospital', 'geoPoint': {'lat': 48.73722, 'lon': -0.57466}}, {'zip': '14100', 'city': 'Lisieux', 'country': 'France', 'facility': 'Lisieux Hospital', 'geoPoint': {'lat': 49.1466, 'lon': 0.22925}}, {'zip': '50009', 'city': 'Saint-Lô', 'country': 'France', 'facility': 'Saint-Lo Hospital', 'geoPoint': {'lat': 49.11624, 'lon': -1.09031}}], 'overallOfficials': [{'name': 'Rémi Sabatier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}, {'name': 'Annette Belin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-07-20', 'type': 'RELEASE'}, {'date': '2017-12-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital, Caen'}}}}