Back to resultsShort Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts (C-SIAM)
Primary Purpose
Prevention of the Suicide
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SMS
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of the Suicide focused on measuring suicide attempt, SMS monitoring, Phone, Prevention control, tertiary healthcare
Eligibility Criteria
Inclusion Criteria:
- Male or female, over 18 years of age and hospitalized;
- Survivor of a suicide attempt;
- Giving informed, dated and signed consent;
- 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.
Exclusion Criteria:
- Patient whose clinical condition is incompatible with the formulation of his non-opposition.
- The patient and his / her caregiver shall not be afforded a protective justice measure.
Sites / Locations
- CHU de Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMS
Arm 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.
Outcomes
Primary Outcome Measures
Measurement of the feasibility of the device by the patient according to a validated questionnaire
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.
Secondary Outcome Measures
The questionnaire measuring the feasibility for the caregiver of such a device
A questionnaire will be provided to the caregiver to measure the feasibility of such a device
Questionnaires on the acceptability of patients and caregivers in relation to the use of this type of monitoring device
Acceptability questionnaires will be provided to patients and caregivers in relation to the use of this type of monitoring device
Qualitative analysis of messages sent to patients during the study.
A qualitative analysis of the messages addressed to the patients during the study will be carried out.
Full Information
NCT ID
NCT03069560
First Posted
February 28, 2017
Last Updated
May 18, 2020
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03069560
Brief Title
Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
Acronym
C-SIAM
Official Title
Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the caregiver after a suicidal act.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of the Suicide
Keywords
suicide attempt, SMS monitoring, Phone, Prevention control, tertiary healthcare
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
SMS
Intervention Description
SMS contact from the caregiver with patient after discharge in intervention group
Primary Outcome Measure Information:
Title
Measurement of the feasibility of the device by the patient according to a validated questionnaire
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The questionnaire measuring the feasibility for the caregiver of such a device
Description
A questionnaire will be provided to the caregiver to measure the feasibility of such a device
Time Frame
6 months
Title
Questionnaires on the acceptability of patients and caregivers in relation to the use of this type of monitoring device
Description
Acceptability questionnaires will be provided to patients and caregivers in relation to the use of this type of monitoring device
Time Frame
6 months
Title
Qualitative analysis of messages sent to patients during the study.
Description
A qualitative analysis of the messages addressed to the patients during the study will be carried out.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, over 18 years of age and hospitalized;
Survivor of a suicide attempt;
Giving informed, dated and signed consent;
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.
Exclusion Criteria:
Patient whose clinical condition is incompatible with the formulation of his non-opposition.
The patient and his / her caregiver shall not be afforded a protective justice measure.
Facility Information:
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Learn more about this trial
Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
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