Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes (DiabCoach)
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|ClinicalTrials.gov Identifier: NCT02128815|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: Coaching||Not Applicable|
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).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||January 2018|
diabetes health coaching + usual diabetes self-management education
Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support
No Intervention: Usual Care
Usual care or self-management education
- change from baseline A1C after one year [ Time Frame: 1 year ]non-fasting venous blood sample (Hemoglobin A1C assay)
- BMI [ Time Frame: change from baseline in BMI at 1 year ]The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
- Change from baseline self-care behaviours at 1 year [ Time Frame: 1 year ]measured by the Diabetes self-care activities scale.
- change from baseline in quality of life at 1 year [ Time Frame: 1 year ]Audit of Diabetes Dependent Quality of Life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128815
|Langs Community Health Centre|
|Cambridge, Ontario, Canada, N3H 4L6|
|Hamilton, Ontario, Canada, L8S 4K1|
|Principal Investigator:||Diana Sherifali, PhD||McMaster University|