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Health Knowledge, Attitudes, PracticeNCT02186327

Integrative Health Coaching in Community Settings

A study testing Integrative Health Coaching in people with Health Knowledge, Attitudes, Practice, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
Health Knowledge, Attitudes, Practice
What is being tested?
Integrative Health Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesUnited States
Study dates
Aug 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Healing with CAARE Inc.

    Durham, North Carolina, 27701

  • Duke Healthy Lifestyles Program at Duke Children's Primary Care

    Durham, North Carolina, 27704

Other trials in United States

About this study

Official title: Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting

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:

Read more

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.

Read the detailed description

Integrative health coaching, based on a curriculum designed and implemented by Duke Integrative Medicine, uses a patient-centered approach that features elements of accountability, self-discovery, and patient-driven goals. It strives to empower patients to enact lifestyle changes situated in the context of their lives, and invites them to identify intrinsic values that might help guide those choices This type of approach is rooted in validated theories of health psychology. Preliminary work using IHC has found this new approach to be effective for improving lifestyle behaviors (diet, exercise, medication adherence) with concomitant improvements in glycemic control in type 2 diabetes, and for reducing the risk of cardiovascular disease (CVD) in patients with traditional risk factors. In addition, program outcomes suggest reduced healthcare spending in patients enrolled in IHC. A large trial to evaluate how this approach will perform in the primary care setting is currently ongoing.

Health coaching and health literacy efforts that are "community-based" or take place in community settings have also been evaluated for effectiveness as well as feasibility and acceptability. Approaches utilized include telephonic coaching and peer coaches, often in an effort to provide increased accessibility. These studies highlight diverse coaching interventions with mixed results. There are no studies of Integrative Health Coaching implemented in non-profit community settings.

Study Procedures

Baseline visit - After screening to confirm eligibility, an in-person baseline visit will be organized with the participant, during which full consent will be obtained. Following subject consent, each participant will be asked to fill out a brief survey instrument on paper consisting of the ISEL-12 and PAM (or Parent PAM for the Healthy Lifestyles cohort). Participants (in the case of the Healthy Lifestyles cohort, pediatric participants and not parents or guardians) will then be weighed without shoes or outer garments using a zeroed electronic scale. Weight will be recorded to the nearest tenth of a pound. Height will be recorded to the nearest tenth of a centimeter using a stadiometer. Body mass index (BMI) will be calculated from these measurements using the conversion formula BMI = weight (kg)/ height (m2). Randomization will occur after collecting baseline measures. If randomized to receive health coaching, the participant (or parent) will receive a handout briefly describing what to expect from their health coaching sessions and how to best prepare. They will also be asked to fill out a "Current and Desired States" form, which is part of the IHC coaching model and will be passed along to coaches for use in the first session.

Integrative Health Coaching Sessions - After completing the baseline visit, each participant randomized to coaching will be scheduled for an initial telephone call (~ 60-75 minutes in length) to discuss the role of a health coach, when and how s/he may be contacted by participants, and an initial participant self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, participants will schedule weekly to biweekly (~ 30-45 minute) calls with their health coach, for a total of 6 coaching calls over a 3-month intervention period. For the Healthy Lifestyles cohort, all telephonic coaching sessions and activities conducted therein will be directed towards the parent or guardian providing consent. While family health goals and the child's weight management may be anticipated areas of focus in these sessions, coaches and clients will not be limited to any particular topics of discussion.

Participants may initiate coaching sessions from their own personal phone, or by using a landline extension on site at CAARE Inc. or Healthy Lifestyles during business hours, depending on which is more convenient for their schedule and budget. This protocol provides no reimbursement for inadvertent phone charges.

Post-intervention follow-up meeting - Three months following baseline (+ or - one week) and after 6 coaching sessions for the IHC group, participants will meet with a member of the research team to complete the same survey instruments from the baseline visit, and to reassess height and weight, using identical methods to those at baseline. At this time, participants randomized to the IHC group will also have the opportunity to offer recorded feedback regarding their experience in a coaching intervention. This feedback will be solicited via an interview guide of pre-drafted questions, after which the participant will have the opportunity to add additional comments. At this point, unless the participant is part of the subset allocated to the focus group (see below), his/her role in the study is completed. After the post-intervention survey has been completed, coaches and clients may agree to continue sessions on an individual basis, although coaches-in-training must clearly communicate that further sessions are not part of the study.

Focus Group regarding impact of coaching on community needs assessment - This portion of the study will recruit a subset of those participants enrolled from the Healing with CAARE Inc. site. All participants previously enrolled, consented and randomized to receive health coaching will be asked to participate in a focus group session of about 1.5 hours regarding community needs assessment; the target participatory goal is 6-8 participants. The session will take place following post-intervention data collection for all participants who received coaching. It will be guided around a series of questions detailed in a separate document, and centered around data from the 2013 State of the County Health Report and 2013 Community Health Assessment Survey Results conducted and reported by the Durham County Health Department (DCHD) and Partnership for a Healthy Durham. 32 Participants will be invited to comment on the results of these assessments relative to their personal experiences, and to offer their perspectives on community needs, current resources or areas for improvement regarding health and wellness. They will also be asked about their experiences in using community resources or identifying community or environmental barriers through their behavior change efforts while receiving coaching. Participants will be asked whether and how their perspectives on community needs or available resources may have changed following coaching, and if and how they intend to utilize or advocate for community resources in the future.

Post-Intervention Qualitative Evaluation In order to learn as much as possible from this community engagement project, after completion of the study intervention, interviews will be conducted with the coaches that delivered the interventions as well as clinical and administrative staff of the respective community sites. These interviews will take place in small groups or individually and may include briefer, follow-up conversations with the same individuals by phone or in person, to clarify responses as needed. The interviews will be recorded for the purposes of subsequent review and analysis. Participants in the interviews will be identified only by their role in the study in any written analysis of interview content.

The interviews will be structured around a series of interview guides, each of which is composed of a series of questions directed at the health coaches, and community staff or providers who referred patients. Participants will also have an opportunity to draft their own questions regarding the study, and common themes of these questions will be explored further in the group conversation.

Interviews will also be conducted with study participants individually, as outlined above, at the time of their post-intervention follow-up visit. As in the provider and staff interviews, the participant interviews will also be structured around interview guide questions, with an opportunity for participants to draft additional questions or share feedback beyond the question prompts.

The interviews will provide feedback regarding feasibility, delivery, resources utilized, and interprofessional communication throughout the study. Specifically, the areas addressed will include reach, effectiveness, adoption, implementation and maintenance, as have been outlined in previous studies and briefs.

Being tested
Integrative Health Coaching
Keywords
Integrative Health Coaching
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrative Health CoachingBehavioural

    Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.

Study groups in NCT02186327
Study groupRoleWhat they receive
Standard careNo interventionThe control arm will continue to receive standard care as they did prior to enrollment.
Integrative health coachingExperimentalSubjects in this arm will receive 6 sessions of integrative health coaching over a 3 month period, in addition to standard care.
Receives: Behavioral: Integrative Health Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject attrition rate

    As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.

    Measured: 3 months from baseline

  2. Duration (in minutes) of coaching sessions.

    In order to establish subject exposure to the main study intervention and to establish feasibility, number and duration of completed sessions will be measured.

    Measured: 3 months from baseline

  3. Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion

    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.

    Measured: up to 6 months (following 3 month timepoint collection for all subjects)

Secondary outcomes (3)
  1. Change in patient activation

    The Patient Activation Measure is a 13-item scale designed for this purpose.

    Measured: Baseline and 3 months

  2. Change in subject perception of interpersonal support

    The Interpersonal Support Evaluation List (ISEL-12) will be used for this purpose.

    Measured: Baseline and 3 months

  3. Change in body mass index

    BMI will be calculated using height measurement from baseline, and weight measurements at baseline and then again at 3 months.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186327
Sponsor's protocol ID
Pro00054909
Status last verified
Jan 2015
First submitted
2 Jul 2014
Last updated
23 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.

    PubMed 16045394
  • Wolever RQ, Dreusicke M, Fikkan J, Hawkins TV, Yeung S, Wakefield J, Duda L, Flowers P, Cook C, Skinner E. Integrative health coaching for patients with type 2 diabetes: a randomized clinical trial. Diabetes Educ. 2010 Jul-Aug;36(4):629-39. doi: 10.1177/0145721710371523. Epub 2010 Jun 9.

    PubMed 20534872
  • Edelman D, Oddone EZ, Liebowitz RS, Yancy WS Jr, Olsen MK, Jeffreys AS, Moon SD, Harris AC, Smith LL, Quillian-Wolever RE, Gaudet TW. A multidimensional integrative medicine intervention to improve cardiovascular risk. J Gen Intern Med. 2006 Jul;21(7):728-34. doi: 10.1111/j.1525-1497.2006.00495.x.

    PubMed 16808774
  • Vorderstrasse AA, Ginsburg GS, Kraus WE, Maldonado MC, Wolever RQ. Health coaching and genomics-potential avenues to elicit behavior change in those at risk for chronic disease: protocol for personalized medicine effectiveness study in air force primary care. Glob Adv Health Med. 2013 May;2(3):26-38. doi: 10.7453/gahmj.2013.035.

    PubMed 24416670
  • Taggart J, Williams A, Dennis S, Newall A, Shortus T, Zwar N, Denney-Wilson E, Harris MF. A systematic review of interventions in primary care to improve health literacy for chronic disease behavioral risk factors. BMC Fam Pract. 2012 Jun 1;13:49. doi: 10.1186/1471-2296-13-49.

    PubMed 22656188
  • Holland SK, Greenberg J, Tidwell L, Malone J, Mullan J, Newcomer R. Community-based health coaching, exercise, and health service utilization. J Aging Health. 2005 Dec;17(6):697-716. doi: 10.1177/0898264305277959.

    PubMed 16377768
  • Holland SK, Greenberg J, Tidwell L, Newcomer R. Preventing disability through community-based health coaching. J Am Geriatr Soc. 2003 Feb;51(2):265-9. doi: 10.1046/j.1532-5415.2003.51068.x.

    PubMed 12558726
  • Steventon A, Tunkel S, Blunt I, Bardsley M. Effect of telephone health coaching (Birmingham OwnHealth) on hospital use and associated costs: cohort study with matched controls. BMJ. 2013 Aug 6;347:f4585. doi: 10.1136/bmj.f4585.

    PubMed 23920348
  • Rubin DL, Freimuth VS, Johnson SD, Kaley T, Parmer J. Training meals on wheels volunteers as health literacy coaches for older adults. Health Promot Pract. 2014 May;15(3):448-54. doi: 10.1177/1524839913494786. Epub 2013 Jul 22.

    PubMed 23877229
  • Nishita C, Cardazone G, Uehara DL, Tom T. Empowered diabetes management: life coaching and pharmacist counseling for employed adults with diabetes. Health Educ Behav. 2013 Oct;40(5):581-91. doi: 10.1177/1090198112465088. Epub 2012 Nov 21.

    PubMed 23174629

Questions about this trial

What is this clinical trial studying?

A study testing Integrative Health Coaching in people with Health Knowledge, Attitudes, Practice, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject attrition rate (time frame: 3 months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186327, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.

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