- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03686670
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
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Brest, France, 29609
- CHRU de Brest
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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