Suicide, AttemptedMeMindNCT03686670
Acceptability Study by Patients Admitted for Suicide and by Medical Staff for Clinical Data Collection Through an E-health Platform
An observational study of Suicide, Attempted, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2016to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Attempted
- Medical subject headings
- Suicide, Attempted
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the feasibility of this intensive data capture technology in patients in real world without economical incentives.
acceptability assessed by the AES scale
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Nov 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofian BERROUIGUET, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686670
- Sponsor's protocol ID
- Memind
- Acronym
- MeMind
- Status last verified
- Aug 2016
- First submitted
- 20 Sep 2018
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability Study SMARTphone to Collect Clinical Data Using the Memind App by Patients and Medical Satff.
- ClinicalTrials.gov ID
- NCT03686670
- Acronym / sponsor ID
- MeMind / Memind
- Conditions
- Suicide, Attempted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofian BERROUIGUET study director
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, Attempted, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of this intensive data capture technology in patients in real world without economical incentives. (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.