The Analysis of Physical, Physiological and Behavioral Data Collected From Sensors That Track the Mental Condition of Psychiatric Patients

NCT03714893 | Unknown

• 1 other identifier: Sheba-17-4754-AC-CTIL
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

An observational study that uses a digital system to collect physiological, physical and behavioral data using worn sensors on psychiatric patients suffering from schizophrenia, bipolar and schizoaffective disorders. The system will enable to analyze the data using a personal digital algorithm in order to detect changes in mental condition and or changes in adherence to medication treatment, and assist in identification of illegal drug usage.

Conditions

Psychiatric Disorders Mood

Outcome Measures

Primary Outcomes (1)

• Detecting changes in the mental health condition of psychiatric patients

  The wrist watch using sensors will collect physiological data(Heart Rate Variability), physical data (Steps per day) and behavioral data(Quality of sleep).The algorithm that exists in the watch analyzes the amount of steps, the sleep quality- total sleep versus movement and restful sleep, and the distance travelled.The data collected from the wrist watch will then be transferred to an app located on the participant's smartphone which will enable the investigators to collect and analyze the data using big data analysis.After collecting the data above,the investigators will look for a correlation between changes in the personal digital algorithm and changes in the mental health condition of psychiatric patients

  6 months

Secondary Outcomes (1)

• Detection of illegal drug usage

  6 months

Interventions

Sensor wrist watch DEVICE

Participants will wear a sensor wrist watch which will collect data

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults ,18-75, who are currently hosipatlized in the psychiatric unit at Sheba Medical Center.

You may qualify if:

• Psychiatric patients diagnosed with schizophrenia, bipolar, or schizoaffective disorder according to the DSM 5
• PANSS and CGI scores are 4 and above
• Participants must have the ability to informed consent
• Own a smartphone android 2.3 or IOS 2010 and above

You may not qualify if:

• Violent or suicidal participant
• Terminal illness
• Dialysis treatment
• Participants who have a legal guardian
• Participants who do not own a personal smartphone

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 22, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share