NCT04169958

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

December 22, 2018

Last Update Submit

November 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlations between collected digital data and suicidality rating score

    Correlations between collected digital data and suicidality rating score.

    1.5 years

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Central Study Contacts

NADAV GOLDENTAL, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2018

First Posted

November 20, 2019

Study Start

February 1, 2020

Primary Completion

November 29, 2020

Study Completion

December 30, 2020

Last Updated

November 20, 2019

Record last verified: 2019-11