Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion
时间窗: 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.
Subject attrition rate
时间窗: 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.
时间窗: 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.
次要结局
- Change in body mass index(Baseline and 3 months)
- Change in patient activation(Baseline and 3 months)
- Change in subject perception of interpersonal support(Baseline and 3 months)