NCT04805294

Brief Summary

The investigators propose to implement a comprehensive Pediatrician Wellbeing Program initiated through and aligning with departmental faculty development and mentorship processes and goals. The Investigators hypothesize that a wellbeing intervention that incorporates an innovative health coaching model to cultivate individual behavior change supportive of one's own and others' wellbeing will lead to improvements in self-reported wellbeing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

March 15, 2021

Last Update Submit

August 2, 2022

Conditions

Keywords

WellbeingBurn OutPhysician Burn OutMindfulness

Outcome Measures

Primary Outcomes (8)

  • Percentage of Persons Who Were Contacted to Enroll in the Study

    Percentage of persons who were contacted to enroll in the study

    through study completion, an average of 180 days

  • Percentage of Persons Who Ultimately Enrolled in the Study

    Potential persons who were contacted for study participation versus the number who ultimately enrolled in the study.

    through study completion, an average of 180 days

  • Percentage of Mentors Who Attended First Session

    Percentage of mentors who attended first session with mentee

    through study completion, an average of 180 days

  • Percentage of Health Coach Visits Scheduled

    Percentage of visits scheduled with health coaches

    through study completion, an average of 180 days

  • Percentage of Health Coach Visits Missed

    Percentage of visits missed with health coaches

    through study completion, an average of 180 days

  • Percentage of Health Coach Visits Attended

    Percentage of visits attended with health coaches

    through study completion, an average of 180 days

  • Percentage of Total Surveys Completed

    Participants are asked to complete 6 surveys at baseline, 4 surveys after 3-months in the program and 7 surveys after 6-months in the program; the measure reports the number of fully executed surveys as a percentage to determine engagement.

    Day 180

  • Percentage of Participants Who Complete the Study

    Percentage of participants who fully complete all visits and surveys in the study

    Day 180

Secondary Outcomes (4)

  • Change in World Health Organization Wellbeing Index (WHO-5) Scores

    Day 1, Day 180

  • Change in Breslau Post Traumatic Stress Disorder (PTSD) Scores

    Day 1, Day 180

  • Change in Perceived Stress Scale (PSS-4) Scores

    Day 1, Day 180

  • Change in Utrecht Work Engagement Scale (UWES) Scores

    Day 1, Day 180

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Assistant, Associate or Full Professor, either in fixed-term and tenure-track positions in the Department of Pediatrics on the UNC main campus, at the time of consent.

You may qualify if:

  • Provision of signed and dated informed consent form.
  • An Assistant, Associate or Full Professor, either in fixed-term and tenure-track positions in the Department of Pediatrics on the UNC main campus, at the time of consent.

You may not qualify if:

  • Not an Assistant, Associate or Full Professor in either fixed-term or tenure-track position within the Department of Pediatrics on the UNC main campus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Kennedy S, Carmack S, Li L, Lin FC, Hatch JE, Chan K, Tolleson-Rinehart S, Noah TL. Coaching Pediatricians for Wellbeing: A Pilot Feasibility and Acceptability Study. Acad Pediatr. 2025 Mar;25(2):102586. doi: 10.1016/j.acap.2024.09.010. Epub 2024 Oct 1.

MeSH Terms

Conditions

Burnout, PsychologicalOccupational Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational Diseases

Study Officials

  • Terry Noah, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 18, 2021

Study Start

September 22, 2020

Primary Completion

February 3, 2022

Study Completion

February 3, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Time Frame
9-36 months
Access Criteria
Approval from an investigator's IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations