Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-06 @ 5:36 PM
Study NCT ID:
NCT02902458
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini International Neuropsychiatric Interview score', 'timeFrame': '48 hours after implantation'}, {'measure': 'Mini International Neuropsychiatric Interview score', 'timeFrame': '2 weeks after implantation'}, {'measure': 'Mini International Neuropsychiatric Interview score', 'timeFrame': '2 months after implantation'}, {'measure': 'Mini International Neuropsychiatric Interview score', 'timeFrame': '4 months after implantation'}, {'measure': 'Mini International Neuropsychiatric Interview score', 'timeFrame': '6 months after implantation'}, {'measure': 'Mini International Neuropsychiatric Interview score', 'timeFrame': '12 months after implantation'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '48 hours after implantation', 'description': "Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire"}, {'measure': 'Quality of life', 'timeFrame': '2 weeks after implantation', 'description': "Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire"}, {'measure': 'Quality of life', 'timeFrame': '2 months after implantation', 'description': "Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire"}, {'measure': 'Quality of life', 'timeFrame': '4 months after implantation', 'description': "Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire"}, {'measure': 'Quality of life', 'timeFrame': '6 months after implantation', 'description': "Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire"}, {'measure': 'Quality of life', 'timeFrame': '12 months after implantation', 'description': "Measure of patient's quality of life using the Short Form (SF) 36 item questionnaire"}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '48 hours after implantation', 'description': 'Measure of state and trait anxiety'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '2 weeks after implantation', 'description': 'Measure of state and trait anxiety'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '2 months after implantation', 'description': 'Measure of state and trait anxiety'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '4 months after implantation', 'description': 'Measure of state and trait anxiety'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '6 months after implantation', 'description': 'Measure of state and trait anxiety'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '12 months after implantation', 'description': 'Measure of state and trait anxiety'}, {'measure': 'Minnesota Living with Heart Failure questionnaire', 'timeFrame': '48 hours after implantation', 'description': 'Evaluation of the quality of life in patients with heart failure'}, {'measure': 'Minnesota Living with Heart Failure questionnaire', 'timeFrame': '2 weeks after implantation', 'description': 'Evaluation of the quality of life in patients with heart failure'}, {'measure': 'Minnesota Living with Heart Failure questionnaire', 'timeFrame': '2 months after implantation', 'description': 'Evaluation of the quality of life in patients with heart failure'}, {'measure': 'Minnesota Living with Heart Failure questionnaire', 'timeFrame': '4 months after implantation', 'description': 'Evaluation of the quality of life in patients with heart failure'}, {'measure': 'Minnesota Living with Heart Failure questionnaire', 'timeFrame': '6 months after implantation', 'description': 'Evaluation of the quality of life in patients with heart failure'}, {'measure': 'Minnesota Living with Heart Failure questionnaire', 'timeFrame': '12 months after implantation', 'description': 'Evaluation of the quality of life in patients with heart failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['implantable cardioverter defibrillator', 'primary prevention', 'psychological follow-up', 'anxiety', 'depression', 'quality of life'], 'conditions': ['Implantable Defibrillator User']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.', 'detailedDescription': 'The implantation of an ICD in primary prevention is known to increase the rates of anxiety and depression, which can reach up to 45% and 35% respectively in this patient population. Several studies have reported that psychological accompaniment for these patients can alleviate the symptoms of anxiety and/or depression. Therefore, we aim to investigate the utility of psychological follow-up for a period of 1 year after first implantation of an ICD for primary prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (aged 18 years or over)\n* indication for implantation of an ICD for primary prophylaxis\n* written informed consent provided\n* patients with social security coverage\n\nExclusion Criteria:\n\n* patients under legal tutorship or guardianship\n* patients with no social security coverage\n* patients still within the exclusion period after participation in another clinical trial, as indicated by the national registry of clinical trial volunteers\n* patients unable to complete the questionnaires (language barriers, mentally deficient, illiteracy or dementia)\n* patients awaiting heart transplant\n* patients who refuse to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT02902458', 'acronym': 'PEACE', 'briefTitle': 'Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study', 'orgStudyIdInfo': {'id': 'P/2014/217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychological follow-up', 'description': 'Patients undergoing implantation of an ICD for primary prevention will have an individual interview with a qualified psychologist in addition to standard medical follow-up.', 'interventionNames': ['Other: Individual interview with a qualified psychologist']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up.'}], 'interventions': [{'name': 'Individual interview with a qualified psychologist', 'type': 'OTHER', 'description': 'Individual, recorded interview with a qualified psychologist to discuss any and all subjects related to the ICD implantation, or any other topics deemed relevant by the patient.', 'armGroupLabels': ['Psychological follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Besancon', 'country': 'France', 'facility': 'CHU Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Alexandre Guignier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besancon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}