- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805294
Pediatrician Wellbeing Program
Coaching a Wellbeing Leadership Culture: Bringing a Pediatrician Wellbeing Program Into Practice
Study Overview
Status
Conditions
Detailed Description
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 can be implemented using existing institutional infrastructure and will lead to improvements in self-reported wellbeing.
This is a nonrandomized pilot study of a convenience sample. Participants will be assigned to 1 of 2 coaches, based upon availability of schedules. Participants who perform research will be assigned to the remote coach whenever possible to avoid potential concerns with the internal coach's dual role as Administrative Director of the Children's Research Institute.
The sample size for this pilot study (up to 30) was selected for feasibility and not power. This study is funded for 1-year and study participation is for 6-months. The study will be conducted at a single site; the University of North Carolina Department of Pediatrics Chapel Hill. Assistant, Associate and Full Professors, tenure-track or fixed-term, on the UNC main campus are eligible.
The Pediatric Wellbeing Program consists of coaching sessions from a certified National Board for Health and Wellness Coach (NBHWC) through the National Board of Medical Examiners. The NBHWC pioneered science-based training, education, and research of health and wellness coaches over the past 15 years. NBHWC became an accredited institution through National Board of Medical Examiners in 2016, providing certification through examination. By using NBHWC-certified coaches, the investigators are adhering to a standard and measured foundational competencies: the knowledge, tasks and skills essential to the practice of health and wellness coaching. Coaches will assist participants in constructing their Wellbeing-Individual Development Plan (Wellbeing-IDP). The Wellbeing-IDP is designed to assist with identifying the participant's vision, goals, and plan for wellbeing; assess current wellbeing with the WHO-5 to identify areas where they have high wellbeing and areas they need to develop; secure support and accountability (e.g., UNC resources, familial, peer, social, professional); and create a timeline for what they want to accomplish when.
As needed, faculty will also receive up to 5 additional coaching sessions from a certified health coach via video conferencing. All coaching sessions will use principles for health coaching, including brief motivational interviewing, self-empowerment and determination, transtheoretical model of stages of change, mindset, sense making, and making SMART goals (Specific, Measurable, Achievable, Relevant, Timely).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Persons Who Were Contacted to Enroll in the Study
Time Frame: through study completion, an average of 180 days
|
Percentage of persons who were contacted to enroll in the study
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through study completion, an average of 180 days
|
|
Percentage of Persons Who Ultimately Enrolled in the Study
Time Frame: through study completion, an average of 180 days
|
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
Time Frame: through study completion, an average of 180 days
|
Percentage of mentors who attended first session with mentee
|
through study completion, an average of 180 days
|
|
Percentage of Health Coach Visits Scheduled
Time Frame: through study completion, an average of 180 days
|
Percentage of visits scheduled with health coaches
|
through study completion, an average of 180 days
|
|
Percentage of Health Coach Visits Missed
Time Frame: through study completion, an average of 180 days
|
Percentage of visits missed with health coaches
|
through study completion, an average of 180 days
|
|
Percentage of Health Coach Visits Attended
Time Frame: through study completion, an average of 180 days
|
Percentage of visits attended with health coaches
|
through study completion, an average of 180 days
|
|
Percentage of Total Surveys Completed
Time Frame: Day 180
|
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
Time Frame: Day 180
|
Percentage of participants who fully complete all visits and surveys in the study
|
Day 180
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in World Health Organization Wellbeing Index (WHO-5) Scores
Time Frame: Day 1, Day 180
|
The WHO-5 is a 5-item measure assessing subjective psychological well-being based on respondent ratings of cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest.
Responses are provided on a 6-point scale: 0 ("at no time") to 5 ("all of the time") according to the proportion of time over the preceding 2 weeks that applied to each attribute.
Scores range from 0-25; higher scores reflect better well-being.
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Day 1, Day 180
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Change in Breslau Post Traumatic Stress Disorder (PTSD) Scores
Time Frame: Day 1, Day 180
|
The Breslau Post Traumatic Stress Disorder screen is a 7-symptom measure assessing presence of PTSD in accordance with Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) and World Health Organization guidelines.
Responses are provided on a 2-point scale: 1 ("Yes") or 0 ("No") in response to 7 questions.
Scores of 4 or more indicate a likelihood of PTSD.
|
Day 1, Day 180
|
|
Change in Perceived Stress Scale (PSS-4) Scores
Time Frame: Day 1, Day 180
|
The Perceived Stress Scale is a 4-item measure, self-report scale that generates a global stress score based on general questions rather than specific experiences.
Response are provided on a 5-point scale: 0 ("Never") to 4 ("very often") according to the proportion of time over the preceding month that applied to each attribute.
Scores range from 0-16.
Scores of 0-7 indicate low to moderate stress; scores of 8-16 indicate moderate to high stress level.
|
Day 1, Day 180
|
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Change in Utrecht Work Engagement Scale (UWES) Scores
Time Frame: Day 1, Day 180
|
The UWES is a 3-item measure assessing engagement in an individual's work based on respondent ratings of vigor, dedication, and absorption.
Responses are provided on a 7-point scale: 0 ("never") to 6 ("always, every day") and averaged.
Scores range from 0-6; scores within 0-4 indicate low engagement and satisfaction in the workplace.
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Day 1, Day 180
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-0987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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