跳至主要内容
临床试验/NCT03714893
NCT03714893Unknown不适用

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

Sheba Medical Center0 个研究点目标入组 30 人开始时间: 2018年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Detecting changes in the mental health condition of psychiatric patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Detecting changes in the mental health condition of psychiatric patients

时间窗: 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

次要结局

  • Detection of illegal drug usage(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Asaf Caspi

Principal investigator

Sheba Medical Center

相似试验

The Analysis of Physical, Physiological and... | 临床试验