Status:
TERMINATED
The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Lead Sponsor:
LivaNova
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to collect both active and passive data using a wearable, multi-sensor device (Verily Study Watch) and phone application (Mood App) which aims to capture mental health s...
Detailed Description
A prospective, observational, exploratory study collecting passive and active behavioral, environmental and physiological data, via the use of an Android smartphone application and Study Watch. This ...
Eligibility Criteria
Inclusion
- All Subjects
- Current consented subject in the RECOVER clinical trial;
- Adult (i.e. ≥ 18 years of age, unless a resident of any U.S. state where the age of majority is 19, in which case must be ≥ 19 years of age);
- Able and willing to provide written informed consent for this sub-study;
- Able and willing to comply with all study procedures;
- Able to read and speak English.
- Phone Application
- Have a personal Google user account or be willing to create and own a personal Google user account;
- Owns a personal Android smartphone with a data plan and is the sole user of that smartphone;
- Agrees to download and maintain the phone application onto personal Android smartphone for the duration of the sub-study;
- Study Watch
- 1\. Willing to comply with Study Watch wearing and recharging requirements
Exclusion
- All Subjects
- 1\. Any condition or situation the Principal Investigator determines as inappropriate for study inclusion
- Phone Application
- No additional exclusion criteria for phone application
- Study Watch
- 1\. Subjects with known severe allergy to nickel or metal jewelry
Key Trial Info
Start Date :
March 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04753385
Start Date
March 23 2021
End Date
September 6 2024
Last Update
December 20 2024
Active Locations (33)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
3
Keck Hospital of USC
Los Angeles, California, United States, 90033
4
SF-Care, Inc.
San Rafael, California, United States, 94901