Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT03069560
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the feasibility of the device by the patient according to a validated questionnaire', 'timeFrame': '6 months', 'description': 'The primary endpoint is the measurement of the feasibility of the device by the patient based on a validated questionnaire. This evaluation will take place during the medical interview that will close the study participation.'}], 'secondaryOutcomes': [{'measure': 'The questionnaire measuring the feasibility for the caregiver of such a device', 'timeFrame': '6 months', 'description': 'A questionnaire will be provided to the caregiver to measure the feasibility of such a device'}, {'measure': 'Questionnaires on the acceptability of patients and caregivers in relation to the use of this type of monitoring device', 'timeFrame': '6 months', 'description': 'Acceptability questionnaires will be provided to patients and caregivers in relation to the use of this type of monitoring device'}, {'measure': 'Qualitative analysis of messages sent to patients during the study.', 'timeFrame': '6 months', 'description': 'A qualitative analysis of the messages addressed to the patients during the study will be carried out.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['suicide attempt', 'SMS monitoring', 'Phone', 'Prevention control', 'tertiary healthcare'], 'conditions': ['Prevention of the Suicide']}, 'referencesModule': {'references': [{'pmid': '30618917', 'type': 'BACKGROUND', 'citation': 'Le Moal V, Lemey C, Walter M, Berrouiguet S. Viewpoint: Toward Involvement of Caregivers in Suicide Prevention Strategies; Ethical Issues and Perspectives. Front Psychol. 2018 Dec 18;9:2457. doi: 10.3389/fpsyg.2018.02457. eCollection 2018. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the caregiver after a suicidal act.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, over 18 years of age and hospitalized;\n* Survivor of a suicide attempt;\n* Giving informed, dated and signed consent;\n* Can be reached by mobile phone. The study is proposed to all adult suicides and to the patient's designated caregiver, meeting the inclusion criteria.\n\nExclusion Criteria:\n\n* Patient whose clinical condition is incompatible with the formulation of his non-opposition.\n* The patient and his / her caregiver shall not be afforded a protective justice measure."}, 'identificationModule': {'nctId': 'NCT03069560', 'acronym': 'C-SIAM', 'briefTitle': 'Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts', 'orgStudyIdInfo': {'id': 'C-SIAM (29.BRC.16.115)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMS', 'description': 'The patients will receive from the caregiver a first SMS 48 hours after their discharge from the hospital then a total of 4 messages : 48 hours, S1, S2, and S4.', 'interventionNames': ['Device: SMS']}], 'interventions': [{'name': 'SMS', 'type': 'DEVICE', 'description': 'SMS contact from the caregiver with patient after discharge in intervention group', 'armGroupLabels': ['SMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}