NCT03069560

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

July 19, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

December 3, 2025

Status Verified

May 1, 2020

Enrollment Period

2.1 years

First QC Date

February 28, 2017

Last Update Submit

November 26, 2025

Conditions

Keywords

suicide attemptSMS monitoringPhonePrevention controltertiary healthcare

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

  • The questionnaire measuring the feasibility for the caregiver of such a device

    6 months

  • Questionnaires on the acceptability of patients and caregivers in relation to the use of this type of monitoring device

    6 months

  • Qualitative analysis of messages sent to patients during the study.

    6 months

Study Arms (1)

SMS

EXPERIMENTAL

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

Interventions

SMSDEVICE

SMS contact from the caregiver with patient after discharge in intervention group

SMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, over 18 years of age and hospitalized;
  • Survivor of a suicide attempt;
  • Giving informed, dated and signed consent;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

Related Publications (1)

  • 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.

    PMID: 30618917BACKGROUND

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

July 19, 2017

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

December 3, 2025

Record last verified: 2020-05

Locations