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Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts (C-SIAM)

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ClinicalTrials.gov Identifier: NCT03069560
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the caregiver after a suicidal act.

Condition or disease Intervention/treatment Phase
Prevention of the Suicide Device: SMS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Suicide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SMS
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.
Device: SMS
SMS contact from the caregiver with patient after discharge in intervention group



Primary Outcome Measures :
  1. Measurement of the feasibility of the device by the patient according to a validated questionnaire [ Time Frame: 6 months ]
    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 :
  1. The questionnaire measuring the feasibility for the caregiver of such a device [ Time Frame: 6 months ]
    A questionnaire will be provided to the caregiver to measure the feasibility of such a device

  2. Questionnaires on the acceptability of patients and caregivers in relation to the use of this type of monitoring device [ Time Frame: 6 months ]
    Acceptability questionnaires will be provided to patients and caregivers in relation to the use of this type of monitoring device

  3. Qualitative analysis of messages sent to patients during the study. [ Time Frame: 6 months ]
    A qualitative analysis of the messages addressed to the patients during the study will be carried out.



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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:

  • 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.

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): NCT03069560


Contacts
Contact: Michel WALTER 02 98 01 51 57 ext +33 michel.walter@chu-brest.fr

Locations
France
CHU de Brest Recruiting
Brest, France, 29609
Contact: Jean-Michel WALTER, Professor       michel.walter@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03069560     History of Changes
Other Study ID Numbers: C-SIAM (29.BRC.16.115)
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
suicide attempt
SMS monitoring
Phone
Prevention control
tertiary healthcare

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