Type 2 Diabetes Clinical Trial
Official title:
Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes
Background: Health coaching is defined as health education, promotion and support by a professional to enhance the well-being of individuals and facilitate the achievement of their health-related goals. However, health coaching has not been adequately assessed in the community health care setting in individuals with T2DM. The purpose of this study is to determine the effect of diabetes health coaching in adults with T2DM in the community health care setting on clinical outcomes, self-care behaviours and health care utilization.
Evaluating the Effect of a Diabetes Health Coach in Individuals with Type 2 Diabetes.
Background: Health coaching is defined as health education, promotion and support by a
professional to enhance the well-being of individuals and facilitate the achievement of their
health-related goals. However, health coaching has not been adequately assessed in the
community health care setting in individuals with T2DM. The purpose of this study is to
determine the effect of diabetes health coaching in adults with T2DM in the community health
care setting on clinical outcomes, self-care behaviours and health care utilization.
Research Questions: In adults with T2DM who are referred to a community based diabetes
program, does assignment to a diabetes health coach that provides remotely delivered frequent
personalized education and support, behaviour modification counselling and reinforcement, and
psychosocial support improve glycated hemoglobin (A1C) over diabetes education alone?
Secondary Questions include: i) Does the assignment to a diabetes health coach improve: a)
body mass index (BMI); b) diabetes self-care activities; and c) quality of life, more than
standard diabetes self-management education alone after one year? ii) What is the incremental
cost-effectiveness of the diabetes health coach relative to standard diabetes self-management
education?
Proposed Design and Intervention:
The study design will be an open-label randomized controlled trial of adults with T2DM in a
Community Health Centre (CHC) setting. Upon randomization to the intervention group, study
participants will receive one-year access to diabetes health coaching, which comprises: a)
weekly access to a coach, via secured messaging or telephone; b) diabetes case management; c)
personalized diabetes education; d) behaviour modification, goal setting and reinforcement;
and d) psychosocial support. All study participants will have access to their standard
diabetes care and access to the Virtual Lifestyle Management program, an internet based
deliverable program which comprises the National Institutes of Health's Diabetes Prevention
Program (DPP) protocol and curriculum, proven to be effective for weight management.
Education includes 24 modules with streaming audio narration; and b) tracking tools to record
dietary and physical activity results. All participants will also receive an accelerometer to
measure physical activity (steps).
Outcome:
The primary outcome is the difference the mean A1C in the diabetes health coaching program,
compared to the mean A1C in the control group at 1 year. Secondary outcomes will include: a)
BMI; b) diabetes self-care activities; c) quality of life; and d) cost-effectiveness.
Implications:
The findings from this trial may support a new strategy to complement and/or enhance diabetes
self-management services in the community. Coaching may be delivered remotely and may
demonstrate to be a cost-effective or cost-neutral service to support those living with
diabetes.
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