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Integrative Health Coaching in Community Settings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02186327
First received: July 2, 2014
Last updated: July 22, 2015
Last verified: January 2015
  Purpose

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.

Primary Hypotheses:

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.

Additional hypotheses:

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 Intervention
Health Knowledge, Attitudes, Practice
Behavioral: Integrative Health Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 74
Study Start Date: August 2014
Study Completion Date: June 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Site one:

  • 18 years or over
  • able to speak and understand English
  • able and willing to give informed consent

Site two (pediatric):

  • pediatric participant is 5-12
  • patient is in care of parent or guardian willing to participate in study intervention and complete baseline and post-intervention surveys and interviews
  • both pediatric patient and parent/guardian can speak and understand English
  • parent/guardian is able and willing to provide consent (pediatric patients age 12 will also provide assent)

Exclusion Criteria:

  • inability to ambulate or participate in physical activity
  • serious chronic disease related complications or conditions that could significantly affect study outcomes (currently treated cancer, renal failure, CVA with residual effects on functioning)
  • concurrent participation in a lifestyle-based intervention study for chronic disease or health behaviors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186327

Locations
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
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Ruth Wolever, PhD Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02186327     History of Changes
Other Study ID Numbers: Pro00054909
Study First Received: July 2, 2014
Last Updated: July 22, 2015

Keywords provided by Duke University:
Integrative Health Coaching

ClinicalTrials.gov processed this record on April 26, 2017