NCT05606887

Brief Summary

This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

October 26, 2022

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Feasibility of Intervention (FIM)

    Feasibility will be measured by the Feasibility of Intervention Measure (FIM)

    Through study completion, on average 6 months

  • Feasibility of Intervention (Study Retention)

    Feasibility will be measured by study retention

    Through study completion, on average 6 months

  • Acceptability of Intervention (AIM)

    Acceptability will be measured by the validated Acceptability of Intervention Measure.

    Through study completion, on average 6 months

  • Acceptability of Intervention (EMA Completion Rates)

    Acceptability will be measured by the open/completion rates of ecological momentary assessment.

    Through study completion, on average 6 months

Secondary Outcomes (4)

  • Anxiety

    Through study completion, on average 6 months

  • Depression

    Through study completion, on average 6 months

  • Professional Burnout

    Through study completion, on average 6 months

  • Post-Traumatic Stress Disorder

    Through study completion, on average 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

In addition to completing 3 surveys over the course of 6 months, participants in the intervention arm will be asked to wear a wearable device (FitBit Charge 5), complete texting-based ecological momentary assessments to gauge real-time feelings of stress, and receive bi-weekly personalized data dashboards to report back their data.

Other: Wearable Device and Ecological Momentary Assessments

Control

NO INTERVENTION

Participants randomized to this arm will receive digital surveys over the course of 6 months (one at baseline, one at 3 months, and one at 6 months). These surveys will be the same as the intervention arm and will ask questions related to burnout, anxiety, depression, PTSD, and stress.

Interventions

The intervention will consist of three components: 1. Completion of brief text-message based surveys 2-3 times per week 2. Wearing a wrist-based wearable device to generate individual data insights on physiological data related to stress and well-being, including heart rate variability, stress scores, and sleep quality 3. Individual biweekly reports of survey response trends and curated resources intended to support participant well-being

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Emergency Medicine (EM) physician or advanced practice provider
  • Daily access to smart phone
  • Ability to use a wrist-worn wearable device
  • Has or is willing to create a Gmail / Google account
  • Provides at least 20 hours per week of clinical care.

You may not qualify if:

  • Under 18
  • Not a Penn EM physician or advanced practice provider
  • Does not have daily access to a smart phone
  • Unwilling or unable to wear a wearable device
  • Does not have or is unwilling to create a Gmail / Google account
  • Does not provide at least 20 hours per week of clinical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Burnout, Professional

Interventions

Wearable Electronic DevicesEcological Momentary Assessment

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and SuppliesPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Given the nature of the intervention (i.e., participants in the intervention arm receiving a wearable device and investigators and analysts reviewing biometric data for this group), the study will not be masked.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be assigned to the intervention arm (with wearable devices or EMAs) or control (survey-only) in parallel and will remain in their assigned arm throughout their participation in the survey.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 7, 2022

Study Start

October 3, 2023

Primary Completion

June 10, 2024

Study Completion

June 10, 2024

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations