The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LivaNova
- 入组人数
- 138
- 试验地点
- 33
- 主要终点
- Percentage of Voice Diary tasks
研究概览
简要总结
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 status, in subjects participating in the RECOVER clinical trial (A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression).
详细描述
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 sub-study is only open to sites participating in the RECOVER clinical study.
All subjects participating in the RECOVER clinical trial at active UNCOVER sites will be offered participation in this sub-study.
Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study.
Subjects who opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Willing to comply with Study Watch wearing and recharging requirements
排除标准
- •All Subjects
- •Any condition or situation the Principal Investigator determines as inappropriate for study inclusion
- •Phone Application
- •No additional exclusion criteria for phone application
- •Study Watch
- •Subjects with known severe allergy to nickel or metal jewelry
结局指标
主要结局
Percentage of Voice Diary tasks
时间窗: Through study completion; Average 2 years
Percentage of Voice Diary tasks completed over the duration of the study
Number of ping sensor recordings
时间窗: Through study completion; Average 2 years
Number of ping sensor recordings over the duration of the study
Number of hours of watch wear time
时间窗: Through study completion; Average 2 years
Number of hours of watch wear time over the duration of the study
Percentage of PHQ-8 tasks
时间窗: Through study completion; Average 2 years
Percentage of PHQ-8 tasks completed over the duration of the study
次要结局
未报告次要终点