Short Message System (SMS) Monitoring Intended for the Suicidal Patients
Primary Purpose
Patients Having Realized a Suicide Attempt
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
SMS contact with patient after discharge in intervention group
Sponsored by
About this trial
This is an interventional prevention trial for Patients Having Realized a Suicide Attempt focused on measuring suicide attempt, SMS monitoring, recurrence, phone, prevention control, tertiary healthcare
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Surviving a suicide attempt
- Leaving directly the emergency department or hospitalized less than 7 days
- Being able to be joined by telephone mobile
Exclusion Criteria:
- under guardianship
- Patient who are not able to provide a consent
Sites / Locations
- CHU Angers
- CHRU de Brest
- CHU Caen
- CHRU Lille
- CHU de Lyon
- CHU Nantes
- CH Quimperlé
- CHU Rennes
- CHU de Saint-Etienne, Hôpital Nord
- CH St Malo
- CHU St Nazaire
- CHU Tours
- CH Vannes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SMS
Without SMS
Arm Description
The patients of the test group receive a first SMS 48 hours after their discharge from the hospital then a total of 10 messages distributed over six months: 48 hours, S1, S2, M1, M2, M3, M4, M5, M6 and M13.
The patients of the group benefit from the usual care.
Outcomes
Primary Outcome Measures
Number of suicide reattempts in every group
Secondary Outcome Measures
Number of suicide reattempts in every group
Total number of suicidal second recurrences in every group
Total number of suicidal second recurrences in every group
Number of deaths by suicide
Score in the scale C-SSRS
Presence of a disorder in the MINI: characterization of the comorbidity
Full Information
NCT ID
NCT02106949
First Posted
April 4, 2014
Last Updated
March 15, 2018
Sponsor
University Hospital, Brest
Collaborators
Technopôle Brest-Iroise: LANESTEL SARL, 38 rue Jim Sevellec, 29200 Brest
1. Study Identification
Unique Protocol Identification Number
NCT02106949
Brief Title
Short Message System (SMS) Monitoring Intended for the Suicidal Patients
Official Title
Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Technopôle Brest-Iroise: LANESTEL SARL, 38 rue Jim Sevellec, 29200 Brest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Having Realized a Suicide Attempt
Keywords
suicide attempt, SMS monitoring, recurrence, phone, prevention control, tertiary healthcare
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMS
Arm Type
Experimental
Arm Description
The patients of the test group receive a first SMS 48 hours after their discharge from the hospital then a total of 10 messages distributed over six months: 48 hours, S1, S2, M1, M2, M3, M4, M5, M6 and M13.
Arm Title
Without SMS
Arm Type
No Intervention
Arm Description
The patients of the group benefit from the usual care.
Intervention Type
Device
Intervention Name(s)
SMS contact with patient after discharge in intervention group
Primary Outcome Measure Information:
Title
Number of suicide reattempts in every group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of suicide reattempts in every group
Time Frame
13 months
Title
Total number of suicidal second recurrences in every group
Time Frame
6 months
Title
Total number of suicidal second recurrences in every group
Time Frame
13 months
Title
Number of deaths by suicide
Time Frame
6 months and 13 months
Title
Score in the scale C-SSRS
Time Frame
inclusion, 6 months and 13 months
Title
Presence of a disorder in the MINI: characterization of the comorbidity
Time Frame
6 months and 13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Surviving a suicide attempt
Leaving directly the emergency department or hospitalized less than 7 days
Being able to be joined by telephone mobile
Exclusion Criteria:
under guardianship
Patient who are not able to provide a consent
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Caen
City
Caen
Country
France
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Name
CHU de Lyon
City
Lyon
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
CH Quimperlé
City
Quimperlé
Country
France
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Name
CHU de Saint-Etienne, Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CH St Malo
City
St Malo
ZIP/Postal Code
35403
Country
France
Facility Name
CHU St Nazaire
City
St Nazaire
Country
France
Facility Name
CHU Tours
City
Tours
Country
France
Facility Name
CH Vannes
City
Vannes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33884617
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.
Results Reference
derived
PubMed Identifier
29321126
Citation
Berrouiguet S, Larsen ME, Mesmeur C, Gravey M, Billot R, Walter M; HUGOPSY Network; Lemey C, Lenca P. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 10;6(1):e8. doi: 10.2196/mhealth.7780.
Results Reference
derived
PubMed Identifier
25404215
Citation
Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-Garcia E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.
Results Reference
derived
Learn more about this trial
Short Message System (SMS) Monitoring Intended for the Suicidal Patients
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