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Completed

NCT Number: NCT02128815

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Langs Community Health Centre, Cambridge, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coaching

Other

Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support

Primary outcomes

  1. change from baseline A1C after one year

    Time frame: 1 year

    non-fasting venous blood sample (Hemoglobin A1C assay)

Secondary outcomes

  1. 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.

  2. Change from baseline self-care behaviours at 1 year

    Time frame: 1 year

    measured by the Diabetes self-care activities scale.

  3. change from baseline in quality of life at 1 year

    Time frame: 1 year

    Audit of Diabetes Dependent Quality of Life

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: DiabCoach

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 1, 2014
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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