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Status unknownNCT04169958Updated Nov 20, 2019

Suicide Risk Assessment by Digital Means

An observational study in Suicide, sponsored by The Chaim Sheba Medical Center. Status unknown. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by The Chaim Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study 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. 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.

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Conditions studied

  • Suicide

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • Every patient who is examined in the psychiatric ward at the Sheba Medical Center
  • Proper ability to give informed consent

Exclusion criteria

Exclusion Criteria:

  • A patient who is not independent and without an active therapist / guardian involved in the treatment
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Othersafe mood

    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

05

What researchers measure

Primary outcomes

  1. Correlations between collected digital data and suicidality rating score

    Correlations between collected digital data and suicidality rating score.

    Time frame: 1.5 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04169958
Lead sponsor
The Chaim Sheba Medical Center
Responsible party
Nadav Goldental (Principal Investigator, The Chaim Sheba Medical Center) — Principal investigator
First posted
Nov 20, 2019
Start date
Feb 1, 2020 (estimated)
Primary completion
Nov 29, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Nov 20, 2019

Study contacts

NADAV GOLDENTAL, MD
Contact
nadav.gold@gmail.com
+972-503363498

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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