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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04805294
Other study ID # 20-0987
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 22, 2020
Est. completion date February 3, 2022

Study information

Verified date August 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 3, 2022
Est. primary completion date February 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Percentage of Mentors Who Attended First Session Percentage of mentors who attended first session with mentee through study completion, an average of 180 days
Primary Percentage of Health Coach Visits Scheduled Percentage of visits scheduled with health coaches through study completion, an average of 180 days
Primary Percentage of Health Coach Visits Missed Percentage of visits missed with health coaches through study completion, an average of 180 days
Primary Percentage of Health Coach Visits Attended Percentage of visits attended with health coaches through study completion, an average of 180 days
Primary 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
Primary Percentage of Participants Who Complete the Study Percentage of participants who fully complete all visits and surveys in the study Day 180
Secondary Change in World Health Organization Wellbeing Index (WHO-5) Scores 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. Day 1, Day 180
Secondary Change in Breslau Post Traumatic Stress Disorder (PTSD) Scores 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
Secondary Change in Perceived Stress Scale (PSS-4) Scores 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
Secondary Change in Utrecht Work Engagement Scale (UWES) Scores 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. Day 1, Day 180
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