Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03714893
Status:
UNKNOWN
Last Update Posted:
2018-10-24
First Post:
2018-10-08
Brief Title:
The Analysis of Physical Physiological and Behavioral Data Collected From Sensors That Track the Mental Condition of Psychiatric Patients
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 treatmentwhether it was the doctors decision or low adherence to medication treatmentThe 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 aspectsincreased heart rate elevated Heart Rate Variability physical aspects such as increased number of steps per day and behavioral aspectsincreased 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 dataHeart Rate Variability physical datanumber of steps per day and the behavioral dataquality of sleep This data will then be collected and analyzed through big data analysis
The data will be collected using wrist watches The sensors will collect the physiological dataHeart Rate Variability physical datanumber of steps per day and the behavioral dataquality of sleep This data will then be collected and analyzed through big data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None