NCT02247271

Brief Summary

This project is a partnership between the University of Victoria and the eleven Diabetes Health Centres in the Fraser Health Region of British Columbia, Canada. The primary goal of this project is to evaluate the feasibility, viability, and effectiveness of using peer health coaches to assist persons with type 2 diabetes who are experiencing challenges in managing their diabetes. The University of Victoria will recruit and train sixty coaches with various cultural and socioeconomic backgrounds representing a community of practice. Coaches will also have type 2 diabetes or be familiar with type 2 diabetes and will have led or taken the Diabetes Self-Management Program in English, Punjabi or in Aboriginal communities. Training will also include navigating the health care system, accessing mandated health and employment- related services, importance of medication adherence and ability to understand health care instructions. One hundred and fifty subjects with type 2 diabetes will be recruited by Diabetes Health Educators or through community newspaper ads. Eligibility criteria for subjects include: adults with type 2 diabetes who speak English or Punjabi living in the Fraser Health region. A one group pre-post matched design will be used. Both participants and coaches will complete questionnaires at baseline, six and twelve months. The Diabetes Coaches will provide assistance to subjects for a period of 6 months. A project community advisory committee comprised of the researchers, Diabetes Centre administrative staff, clinicians, coaches, subjects, key community leaders and representatives from the diabetes industry will meet every three months to guide implementation and sustainability. Qualitative research methods (i.e., focus groups and interviews) will be used to gather feedback, perspectives, and opinions of all the stakeholders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

3.1 years

First QC Date

September 18, 2014

Last Update Submit

May 1, 2018

Conditions

Keywords

peer coaches

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure (PAM)

    This is a composite measure

    one year

Secondary Outcomes (11)

  • glycated hemoglobin test (A1C)

    one year

  • Diabetes Empowerment Scale (DES)

    one year

  • Self-efficacy

    one year

  • Self-reported health

    one year

  • Fatigue

    one year

  • +6 more secondary outcomes

Study Arms (1)

Diabetes health coach support

OTHER

The intervention is that subjects will receive coach support once a week for 30 minutes for six months. Support is provided by a Diabetes Coach who uses self-management support strategies to assist subjects to achieve their personal health goals.

Behavioral: Diabetes health coach support

Interventions

Receives support from a trained peer health coach for a six month period

Diabetes health coach support

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults, living in Fraser Health Region of British Columbia, type 2 diabetes, ability to speak English or Punjabi

You may not qualify if:

  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVictoria

Delta, British Columbia, V4K 2K6, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Patrick T McGowan, PhD

    University of Victoria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Public Health and Social Policy

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 25, 2014

Study Start

September 1, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations