SuicideNCT04169958
Suicide Risk Assessment by Digital Means
An observational study of Suicide, run by The Chaim Sheba Medical Center.
Trial summary
This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide
- What is being tested?
- safe mood
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 30 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will recruit a total sample of N=50 in three stages: * Males and Females * 30 patients aged 12 - 18 years old (20% of the study sample) Participants will be recruited from the psychiatric ER (~50%), outpatient clinics (~20%), and inpatient wards (~30%) at the Sheba Medical Center, the largest hospital in Israel, serving a very large, demographically heterogenic and socioeconomically diverse population. * Psychiatric diagnosis: None, Affective Disorder, PTSD, ADHD, Personality Disorder, Anxiety Disorder, OCD.
Who may be able to join
- Every patient who is examined in the psychiatric ward at the Sheba Medical Center
- Proper ability to give informed consent
Who cannot join
- A patient who is not independent and without an active therapist / guardian involved in the treatment
Trial locations and contacts
No sites are listed yet.
About this study
This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients.
The system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately).
Read more
The data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior.
After the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously.
Note that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.
- Conditions
- Suicide
- Being tested
- safe mood
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safe moodOther
A tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between collected digital data and suicidality rating score
Correlations between collected digital data and suicidality rating score.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Feb 2020 (estimated)
- Primary completion29 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Chaim Sheba Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadav Goldental, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169958
- Sponsor's protocol ID
- SHEBA-18-5152-NG-CTIL
- Status last verified
- Nov 2019
- First submitted
- 22 Dec 2018
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Risk Assessment by Digital Means
- ClinicalTrials.gov ID
- NCT04169958
- Acronym / sponsor ID
- SHEBA-18-5152-NG-CTIL
- Conditions
- Suicide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Chaim Sheba Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 29 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 20 Nov 2019 (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.
This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients.
The system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately).
The data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior.
After the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously.
Note that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will recruit a total sample of N=50 in three stages: * Males and Females * 30 patients aged 12 - 18 years old (20% of the study sample) Participants will be recruited from the psychiatric ER (~50%), outpatient clinics (~20%), and inpatient wards (~30%) at the Sheba Medical Center, the largest hospital in Israel, serving a very large, demographically heterogenic and socioeconomically diverse population. * Psychiatric diagnosis: None, Affective Disorder, PTSD, ADHD, Personality Disorder, Anxiety Disorder, OCD.
Key inclusion criteria (2 listed)
- Every patient who is examined in the psychiatric ward at the Sheba Medical Center
- Proper ability to give informed consent
Key exclusion criteria (1 listed)
- A patient who is not independent and without an active therapist / guardian involved in the treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| safe moodA tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide | Other | – |
Primary outcome
Correlations between collected digital data and suicidality rating score
Time frame: 1.5 years
Correlations between collected digital data and suicidality rating score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, run by The Chaim Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NADAV GOLDENTAL, MD (+972-503363498, nadav.gold@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between collected digital data and suicidality rating score (time frame: 1.5 years). 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 20 Nov 2019.