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

March 27, 2018 updated by: McMaster University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N3H 4L6
        • Langs Community Health Centre
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coaching
diabetes health coaching + usual diabetes self-management education
Other: Coaching
Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support
NO_INTERVENTION: Usual Care
Usual care or self-management education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline A1C after one year
Time Frame: 1 year
non-fasting venous blood sample (Hemoglobin A1C assay)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 in BMI at 1 year
Change from baseline self-care behaviours at 1 year
Time Frame: 1 year
measured by the Diabetes self-care activities scale.
1 year
change from baseline in quality of life at 1 year
Time Frame: 1 year
Audit of Diabetes Dependent Quality of Life
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Diana Sherifali, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (ESTIMATE)

May 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Coaching2014#

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This option is still being explored.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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