Healthcare Worker Resilience as Measured by Physiologic F... | NCT05033379

Studies
Healthcare Worker Resilience as Measured by Physiologic Feedback

NCT05033379

Sponsor

Stanford University

Status

Unknown status

Last Update Posted

Mar 28, 2024Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Burnout, Professional

Interventions

Control
Resilience coaching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2023Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Aug 17, 2021

First Submission Date that Met QC Criteria

Aug 27, 2021

First Posted Date

Sep 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2024

Last Update Posted Date

Mar 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cindy Kin, Assistant Professor of Surgery, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.

Detailed Description

Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study.

Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching.

Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Arm	Experimental	Instruction about importance of sleep.	Behavioral: Control
Coaching	Experimental	Undergo resilience coaching	Behavioral: Resilience coaching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control	Behavioral	Importance of sleep	Control Arm
Resilience coaching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recovery	Using WHOOP algorithm, recovery will be quantified using heart rate variability and sleep, and serve as a measure of stress and resilience	6 months

Secondary Outcomes

Measure	Description	Time Frame
Burnout	The Physician Fulfillment Index is a quantitative measure of physician burnout and will be administered at baseline and at the end of the study.	6 months
Health Habits	Changes in sleep metrics (duration of sleep, quality of sleep, and pre-sleep habits including light exposure and eating habits before sleep) and diet habits (evaluated by dietary pattern, ie, traditional Westernized, healthy Mediterranean, unhealthy - animal protein and alcohol, at beginning and end of the study) will be assessed

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study participants will include full time clinically active healthcare workers

Exclusion Criteria:

Exclusion criteria will be anyone who is not a full-time clinical healthcare worker

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Health Care		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002055	Burnout, Professional

Ancestor Terms

ID	Term
D000073397	Occupational Stress
D009784	Occupational Diseases
D000077062	Burnout, Psychological
D013315	Stress, Psychological

Browse Leaves

Not provided

Browse Branches

Not provided