The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes (UNCOVER)
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ClinicalTrials.gov Identifier: NCT04753385 |
Recruitment Status :
Active, not recruiting
First Posted : February 15, 2021
Last Update Posted : May 16, 2024
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Tracking Information | |||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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. |
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Condition | Treatment Resistant Depression | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
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
Phone Application
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 |
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Sex/Gender |
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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 | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04753385 | ||||
Other Study ID Numbers | LND300 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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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 |
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PRS Account | LivaNova | ||||
Verification Date | May 2024 |