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Short Message System (SMS) Monitoring Intended for the Suicidal Patients

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ClinicalTrials.gov Identifier: NCT02106949
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : October 31, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Patients Having Realized a Suicide Attempt Device: SMS contact with patient after discharge in intervention group Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
Study Start Date : August 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SMS
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.
Device: SMS contact with patient after discharge in intervention group
No Intervention: Without SMS
The patients of the group benefit from the usual care.


Outcome Measures

Primary Outcome Measures :
  1. Number of suicide reattempts in every group [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of suicide reattempts in every group [ Time Frame: 13 months ]
  2. Total number of suicidal second recurrences in every group [ Time Frame: 6 months ]
  3. Total number of suicidal second recurrences in every group [ Time Frame: 13 months ]
  4. Number of deaths by suicide [ Time Frame: 6 months and 13 months ]
  5. Score in the scale C-SSRS [ Time Frame: inclusion, 6 months and 13 months ]
  6. Presence of a disorder in the MINI: characterization of the comorbidity [ Time Frame: 6 months and 13 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106949


Contacts
Contact: Michel WALTER, Pr michel.walter@chu-brest.fr

Locations
France
CHU Angers Recruiting
Angers, France
Contact: Bénédicte Gohier, Pr         
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Sofian BERROUIGUET, Dr         
Principal Investigator: Sofian BERROUIGUET, Dr         
CHU Caen Recruiting
Caen, France
Contact: Françoise CHASTANG, Dr         
Principal Investigator: Françoise CHASTANG, Dr         
Sub-Investigator: Alina HAIVAS         
CHRU Lille Recruiting
Lille, France
Contact: Guillaume VAIVA, Pr         
CHU de Lyon Not yet recruiting
Lyon, France
Contact: Emmanuel POULET         
Principal Investigator: Emmanuel POULET         
CHU Nantes Recruiting
Nantes, France
Contact: Virginie Lagrée, Dr         
CH Quimperlé Terminated
Quimperlé, France
CHU Rennes Recruiting
Rennes, France
Contact: David Travers, Dr         
CHU de Saint-Etienne, Hôpital Nord Recruiting
Saint Etienne, France, 42055
Contact: Catherine MASSOUBRE, Pr         
Sub-Investigator: Clothilde COUDROT, Dr         
Principal Investigator: Catherine MASSOUBRE, Pr         
CH St Malo Recruiting
St Malo, France, 35403
Contact: Dijkstra SYTZE, Dr         
Principal Investigator: Dijkstra SYTZE, Dr         
CHU St Nazaire Recruiting
St Nazaire, France
Contact: Patrick Delbrouck, Dr         
CHU Tours Recruiting
Tours, France
Contact: Wissam El Hage, Dr         
CH Vannes Recruiting
Vannes, France
Contact: Isabelle DORMOIS-MARTINEZ, Dr         
Sponsors and Collaborators
University Hospital, Brest
Technopôle Brest-Iroise: LANESTEL SARL, 38 rue Jim Sevellec, 29200 Brest
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02106949     History of Changes
Other Study ID Numbers: SIAM
RB 13-068 [CHRU Brest]
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by University Hospital, Brest:
suicide attempt, SMS monitoring, recurrence, phone, prevention control, tertiary healthcare

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms