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

Type 2 Diabetes Clinical Trial

— DiabCoach  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128815
• Other study ID #: Coaching2014#
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: March 27, 2018
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: September 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Coaching
Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support

Locations

Country	Name	City	State
Canada	Langs Community Health Centre	Cambridge	Ontario
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline A1C after one year	non-fasting venous blood sample (Hemoglobin A1C assay)	1 year
Secondary	BMI	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
Secondary	Change from baseline self-care behaviours at 1 year	measured by the Diabetes self-care activities scale.	1 year
Secondary	change from baseline in quality of life at 1 year	Audit of Diabetes Dependent Quality of Life	1 year