The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes (UNCOVER)

• ClinicalTrials.gov Identifier: NCT04753385
• Recruitment Status: Active, not recruiting
• First Posted: February 15, 2021
• Last Update Posted: May 16, 2024
• Sponsor: LivaNova
• Information provided by (Responsible Party): LivaNova

Tracking Information

• First Submitted Date: January 7, 2021
• First Posted Date: February 15, 2021
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: March 23, 2021
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2021)

• Percentage of PHQ-8 tasks [ Time Frame: Through study completion; Average 2 years ]
  Percentage of PHQ-8 tasks completed over the duration of the study
• Percentage of Voice Diary tasks [ Time Frame: Through study completion; Average 2 years ]
  Percentage of Voice Diary tasks completed over the duration of the study
• Number of ping sensor recordings [ Time Frame: Through study completion; Average 2 years ]
  Number of ping sensor recordings over the duration of the study
• Number of hours of watch wear time [ Time Frame: Through study completion; Average 2 years ]
  Number of hours of watch wear time over the duration of the study

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
• Official Title: The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
• 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 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).

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 sub-study is only open to sites participating in the RECOVER clinical study.

All subjects participating in the RECOVER clinical trial that currently own an Android smartphone 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 also 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

This sub-study is only open to sites participating in the RECOVER clinical study.

Every subject that currently owns an Android smartphone will be offered to opt-in to the sub-study.

• Condition: Treatment Resistant Depression
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 10, 2021): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

All Subjects

1. Current consented subject in the RECOVER clinical trial;
2. 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);
3. Able and willing to provide written informed consent for this sub-study;
4. Able and willing to comply with all study procedures;
5. Able to read and speak English.

Phone Application

1. Have a personal Google user account or be willing to create and own a personal Google user account;
2. Owns a personal Android smartphone with a data plan and is the sole user of that smartphone;
3. 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 Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04753385
• Other Study ID Numbers: LND300
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: LivaNova
• Original Responsible Party: Same as current
• Current Study Sponsor: LivaNova
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Charles Conway, MD; Washington University School of Medicine

• PRS Account: LivaNova
• Verification Date: May 2024