Integrative Health Coaching in Community Settings
|ClinicalTrials.gov Identifier: NCT02186327|
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 23, 2015
This study examines a pilot project to introduce integrative health coaching to two community clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month period at no cost by coaching trainees completing their certification hours. Pre and post measurements of BMI, patient activation, and perceived interpersonal support will be collected and analyzed for interaction effects. Qualitative process evaluation will be conducted as a thematic analysis via guided interviews with stakeholders and participants, using the "RE-AIM" framework. Feasibility measures will include recruitment of both coaches and clients, subject/client retention, and number and duration of coaching sessions completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a post-intervention focus group that addresses the impact of coaching on perception of health-related resources and needs in the community.
Integrative health coaching will be a feasible intervention in both community and clinical settings, in terms of required resources, patient or client adherence, and satisfaction by community stakeholders, including providers and participants.
Individuals who receive integrative health coaching sessions as an adjunct to their standard medical care will see improvements in patient activation and perception of interpersonal supports, when compared to controls.
Individuals who receive integrative health coaching (or in the case of the pediatric cohort, children of individuals who receive coaching) will see minor improvements in BMI over the study period when compared to controls.
|Condition or disease||Intervention/treatment||Phase|
|Health Knowledge, Attitudes, Practice||Behavioral: Integrative Health Coaching||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
No Intervention: Standard care
The control arm will continue to receive standard care as they did prior to enrollment.
Experimental: Integrative health coaching
Subjects in this arm will receive 6 sessions of integrative health coaching over a 3 month period, in addition to standard care.
Behavioral: Integrative Health Coaching
Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.
- Subject attrition rate [ Time Frame: 3 months from baseline ]As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.
- Duration (in minutes) of coaching sessions. [ Time Frame: 3 months from baseline ]In order to establish subject exposure to the main study intervention and to establish feasibility, number and duration of completed sessions will be measured.
- Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion [ Time Frame: up to 6 months (following 3 month timepoint collection for all subjects) ]RE-AIM interview guides will tailored to subjects, health coaches, and site personnel will solicit qualitative information for process evaluation, which is the primary purpose of this study.
- Change in patient activation [ Time Frame: Baseline and 3 months ]The Patient Activation Measure is a 13-item scale designed for this purpose.
- Change in subject perception of interpersonal support [ Time Frame: Baseline and 3 months ]The Interpersonal Support Evaluation List (ISEL-12) will be used for this purpose.
- Change in body mass index [ Time Frame: Baseline and 3 months ]BMI will be calculated using height measurement from baseline, and weight measurements at baseline and then again at 3 months.
- Subject perception of community health-related resources and needs following intervention completion [ Time Frame: up to 6 months (following 3 month timepoint for all subjects at the CAARE Inc. site)) ]A focus group will provide qualitative data on subject perception of community resources and community health-related needs for those participants at the CAARE site who received health coaching.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186327
|United States, North Carolina|
|Healing with CAARE Inc.|
|Durham, North Carolina, United States, 27701|
|Duke Healthy Lifestyles Program at Duke Children's Primary Care|
|Durham, North Carolina, United States, 27704|
|Principal Investigator:||Ruth Wolever, PhD||Duke University|