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

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03714893

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Disorders Mood	Device: Sensor wrist watch

Detailed Description

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. It is a known fact that patients suffering from these disorders are more prone to changes in their mental health condition. Sometimes this change is due to change in medical treatment(whether it was the doctor's decision or low adherence to medication treatment).The mental health condition influences physiological, physical and behavioral aspects which could be detected through the personal digital algorithm and could prevent psychiatric deterioration. For example, in a case of a person in a manic episode investigators would expect to find changes in the personal digital algorithm in physiological aspects(increased heart rate, elevated Heart Rate Variability), physical aspects such as increased number of steps per day, and behavioral aspects(increased hours spent outside of home, excessive activity). An early detection can help in the prevention of psychiatric deterioration in this case and help minimize the suffering caused to the patient and caregivers and perhaps assist in minimizing the need for hospitalization.

The data will be collected using wrist watches. The sensors will collect the physiological data(Heart Rate Variability), physical data(number of steps per day) and the behavioral data(quality of sleep). This data will then be collected and analyzed through big data analysis.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Analysis of Physical Physiological and Behavioral Data Collected From Sensors That Track the Mental Condition of Psychiatric Patients Who Are at Risk for Relapse and Who do Not Abide With Their Medication Treatment

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Outcome Measures

Primary Outcome Measures

Detecting changes in the mental health condition of psychiatric patients [6 months]
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

Secondary Outcome Measures

Detection of illegal drug usage [6 months]
Illegal drug usage can contribute to changes in the personal digital algorithm due to changes in physiological(Heart rate Variability) and physical data(Quality of Sleep) collected from the sensors of the wrist watch and analyzed through big data analysis. Early detection can help in minimizing deterioration of the mental health condition

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Asaf Caspi, Principal investigator, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03714893

Other Study ID Numbers:

Sheba-17-4754-AC-CTIL

First Posted:

Oct 22, 2018

Last Update Posted:

Oct 24, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mental Disorders

Problem Behavior

Mood Disorders

Study Results

No Results Posted as of Oct 24, 2018