Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-27 @ 10:58 AM
Study NCT ID:
NCT04366466
Status:
UNKNOWN
Last Update Posted:
2020-04-30
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Program to Promote Engagement in Care for the Prevention of Recidivism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Controlled, randomized and prospective study of a cohort of suicide victims comparing an experimental (interventional) group to a control group (usual treatment)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression (CGI)', 'timeFrame': 'Day 0', 'description': 'rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.'}, {'measure': 'Suicide Intent Scale', 'timeFrame': 'Day 0', 'description': 'The Suicide Intent Scale (SIS) developed by A.T. BECK in 1974, is the only scale that focuses solely on the assessment of the suicide attempt that has just taken place.'}, {'measure': 'Montgomery-Asberg depression rating scale', 'timeFrame': 'Day 0', 'description': 'This scale is widely used to measure the changes brought about by the treatment of depression. It assesses the severity of symptoms in a wide variety of areas such as mood, sleep and appetite, physical and mental fatigue, and thoughts of suicide.'}], 'secondaryOutcomes': [{'measure': 'Evaluating the effectiveness of the P.E.P.S. program in preventing suicidal recidivism', 'timeFrame': '1 year', 'description': 'percentage of all suicidants who relapse during the 12-month study period.'}, {'measure': 'Evaluate the level of possible generalization of the program', 'timeFrame': '1 year', 'description': 'percentage of all suicides of subjects likely to benefit from the program (subjects fulfilling the inclusion and non-inclusion criteria).'}, {'measure': 'Evaluate the feasibility of the program', 'timeFrame': '1 year', 'description': 'percentage of subjects included in the intervention group who received all interventions); weighted by the percentage of acceptance to participate in the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide', 'Health Care Seeking Behavior', 'Case Management']}, 'referencesModule': {'references': [{'pmid': '33884617', 'type': 'DERIVED', 'citation': 'Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.'}]}, 'descriptionModule': {'briefSummary': 'In France, the number of emergency visits for suicide attempts is estimated at 220,000 per year. Suicide management aims to reduce suicide risk factors in order to improve the mental health of patients and prevent recurrences.\n\nTo day, no study has compared the approaches to health surveillance and case management in a clinical trial, nor established the benefit of each on commitment to care and beyond the prevention of suicidal recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18.\n* Male and female.\n* Admission to CH St Denis for a suicide attempt.\n* Referral for outpatient follow-up.\n* Patient with no psychiatric follow-up or who has been out of follow-up for at least three months.\n* Patient having given their written informed consent.\n\nExclusion Criteria:\n\n* Patients not affiliated with social security or state medical aid.\n* Patients who do not have the required faculties to be evaluated (cognitive and delusional disorders).\n* Patients treated for more than 72 hours after their procedure (maximum length of stay in the UAS and/or in medical intensive care.\n* Patient currently under psychiatric care.\n* Patients who cannot be called back by telephone (no telephone, homeless, incarceration).\n* Patients who do not master the French language.'}, 'identificationModule': {'nctId': 'NCT04366466', 'acronym': 'PEPS', 'briefTitle': 'Program to Promote Engagement in Care for the Prevention of Recidivism', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Program to Promote Commitment to Care for the Prevention of Suicidal Recurrence (Health Monitoring and Case Management) Versus Usual Treatment (Health Monitoring): Randomized Controlled Interventional Study in Routine Care.', 'orgStudyIdInfo': {'id': '10477M-PEPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'suicide attempt patient who will receive sanitory supervision', 'description': 'The control group will establish the health monitoring', 'interventionNames': ['Other: suicide attempt patient using PEPS Program']}, {'type': 'EXPERIMENTAL', 'label': 'Suicide attempt patient who will participate to PEPS Program', 'description': 'The intervention group will test the program of Promotion of Commitment to Care for the Prevention of Suicidal Recidivism.', 'interventionNames': ['Other: suicide attempt patient using PEPS Program']}], 'interventions': [{'name': 'suicide attempt patient using PEPS Program', 'type': 'OTHER', 'otherNames': ['Suicide attempt patient using sanitary supervision'], 'description': 'The research protocol consists of two phases separated by randomization.\n\nA Hospital Phase common to both groups:\n\nDay zero is the day of the suicide attempt for which the patient came to the hospital.\n\nA post-hospital phase including the P.E.P.S. program for the intervention group and telephone reminders for the usual treatment group.', 'armGroupLabels': ['Suicide attempt patient who will participate to PEPS Program', 'suicide attempt patient who will receive sanitory supervision']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Youcef BENCHERIF', 'role': 'CONTACT', 'email': 'y.bencherif@epsve.fr', 'phone': '01.43.09.32.32'}, {'name': 'Rusheenthira THAVASEELAN', 'role': 'CONTACT', 'email': 'r.thavaseelan@epsve.fr', 'phone': '0143.0932.32'}], 'overallOfficials': [{'name': 'Fayçal MOUAFFAK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigateur Principal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Januel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of clinical research unit', 'investigatorFullName': 'Januel', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}