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Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes (DiabCoach)

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McMaster University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Other: Coaching

Study type

Interventional

Funder types

Other

Identifiers

NCT02128815
Coaching2014#

Details and patient eligibility

About

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.

Full description

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.

Enrollment

366 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • adults 18 years of age or older
  • diagnosed type 2 diabetes
  • A1C equal to or over 7.5%
  • able to read, write and understand English
  • have telephone or internet access

Exclusion criteria

  • adults with impaired cognition
  • cohabiting with a participant in the study
  • pregnant or planning a pregnancy
  • have an underlying medical condition that may provide misleading A1C levels

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

366 participants in 2 patient groups

Coaching
Experimental group
Description:
diabetes health coaching + usual diabetes self-management education
Treatment:
Other: Coaching
Usual Care
No Intervention group
Description:
Usual care or self-management education

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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