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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coaching
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes focused on measuring adults, coaching, type 2 diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Langs Community Health Centre
  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coaching

Usual Care

Arm Description

diabetes health coaching + usual diabetes self-management education

Usual care or self-management education

Outcomes

Primary Outcome Measures

change from baseline A1C after one year
non-fasting venous blood sample (Hemoglobin A1C assay)

Secondary Outcome Measures

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 self-care behaviours at 1 year
measured by the Diabetes self-care activities scale.
change from baseline in quality of life at 1 year
Audit of Diabetes Dependent Quality of Life

Full Information

First Posted
April 28, 2014
Last Updated
March 27, 2018
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02128815
Brief Title
Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes
Acronym
DiabCoach
Official Title
Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
adults, coaching, type 2 diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coaching
Arm Type
Experimental
Arm Description
diabetes health coaching + usual diabetes self-management education
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care or self-management education
Intervention Type
Other
Intervention Name(s)
Coaching
Intervention Description
Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support
Primary Outcome Measure Information:
Title
change from baseline A1C after one year
Description
non-fasting venous blood sample (Hemoglobin A1C assay)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
BMI
Description
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.
Time Frame
change from baseline in BMI at 1 year
Title
Change from baseline self-care behaviours at 1 year
Description
measured by the Diabetes self-care activities scale.
Time Frame
1 year
Title
change from baseline in quality of life at 1 year
Description
Audit of Diabetes Dependent Quality of Life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Sherifali, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Langs Community Health Centre
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N3H 4L6
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
This option is still being explored.
Citations:
PubMed Identifier
33582039
Citation
Sherifali D, Brozic A, Agema P, Punthakee Z, McInnes N, O'Reilly D, Usman Ali RM, Ibrahim S, Gerstein HC. Effect of Diabetes Health Coaching on Glycemic Control and Quality of Life in Adults Living With Type 2 Diabetes: A Community-Based, Randomized, Controlled Trial. Can J Diabetes. 2021 Oct;45(7):594-600. doi: 10.1016/j.jcjd.2020.11.012. Epub 2020 Dec 5.
Results Reference
derived

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

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