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

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ClinicalTrials.gov Identifier: NCT02128815
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE April 28, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
change from baseline A1C after one year [ Time Frame: 1 year ]
non-fasting venous blood sample (Hemoglobin A1C assay)
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
change from baseline A1C after one year [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT02128815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • 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 self-care behaviours at 1 year [ Time Frame: 1 year ]
    measured by the Diabetes self-care activities scale.
  • change from baseline in quality of life at 1 year [ Time Frame: 1 year ]
    Audit of Diabetes Dependent Quality of Life
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
  • BMI [ Time Frame: 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.
  • change from baseline in quality of life at 1 year [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes
Official Title  ICMJE Evaluating the Effect of a Diabetes Health Coach in Individuals With Type 2 Diabetes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Other: Coaching
Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support
Study Arms  ICMJE
  • Experimental: Coaching
    diabetes health coaching + usual diabetes self-management education
    Intervention: Other: Coaching
  • No Intervention: Usual Care
    Usual care or self-management education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
366
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
370
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128815
Other Study ID Numbers  ICMJE Coaching2014#
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: This option is still being explored.
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Diana Sherifali, PhD McMaster University
PRS Account McMaster University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP