Acceptability Study by Patients Admitted for Suicide and by Medical Staff for Clinical Data Collection Through an E-health Platform (MeMind)

May 29, 2019 updated by: University Hospital, Brest

Acceptability Study SMARTphone to Collect Clinical Data Using the Memind App by Patients and Medical Satff.

The study goal is to determine the feasbility and interest of monitoring mental health and non mental health related simptoms in Outpatients in order to prevent suicide.

Study Overview

Status

Completed

Conditions

Detailed Description

Taking into account the strengths and pitfalls of existing suicide risk assessment methods, we have designed a system capable to combine EMA and continuous monitoring of patients using the smartphone's and/or wearable's sensors and data entry in order to monitor and predict suicide risk. For example, both poor sleep quality and disturbed appetite are clinical markers of depression, with a bidirectional relationship. Their changes could precede the increase of suicidal behavior as sleep and appetite are both influenced by mood state and regulated by the serotonergic system. Our hypothesis is that tracking mental health simptoms regularly through self-report could serve as a consistent and non-biased shortcut to assess mood state, its biological underpinnings and could potentially predict suicidal behavior.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

After agreeing to participate, clinician will collect the non-opposition for each patient. Patient with a current suicidal behavior disorder (according to DSM-5), i.e. having attempted suicide in the current year, will be test the application.

Description

To be eligible for the study, patients must be 18 years or older, attend an outpatient clinic or emergency departments of participating clinical services and owning an android or IOS smartphone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility of this intensive data capture technology in patients in real world without economical incentives.
Time Frame: 2 month
acceptability assessed by the AES scale
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Sofian BERROUIGUET, CHRU de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Memind

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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