- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247271
The Role and Effectiveness of Diabetes Coaches in British Columbia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SUBJECT RECRUITMENT. Recruitment will take place during the first year by Diabetes Centre Educators in the Fraser Health region and through community newspaper ads. In total, 150 subjects will be recruited, along with 60 coaches. Diabetes Centre Educators will refer interested clients who will be contacted by the study coordinator. Persons responding to community newspaper ads will contact the study coordinator directly. Interested subjects will receive a full description of the study and confirm that they want to register. A package containing the Fraser Health Consent Form and a set of questionnaires will be mailed to them.
DIABETES COACH RECRUITMENT AND TRAINING. Recruitment and training will occur in the first 6 months. Criteria includes: living in the Fraser Health Region, adults, having type 2 diabetes or living with someone who has type 2 diabetes, and having similar cultural and ethnic background as members of the community. The coaches will most likely have already completed participation in a self-management program and therefore be knowledgeable in using self-management support strategies.
Competency-based training will be conducted to alleviate potential health professional concerns regarding the quality of service provided by non-professionals. Based on the experience using health workers to assist patients with diabetes (14), our project will provide a six-week training which will include:
- self-management support strategies as per the Five As approach (15);
- the Training Curriculum for Health Coaches (16);
- using behavioural change strategies on exercise, eating habits, smoking, and alcohol use developed by the national Service's Health Trainer Manual (17);
- basic information on diabetes and associated chronic diseases;
- finding and using governmental and community services;
- navigating the health care system; and if required
- completing the Diabetes Self-Management Program. Health coaches will undergo a final exam to receive certification from the University of Victoria. Subjects will be paired with a diabetes coach by the study coordinator. An innovative aspect of the proposed research is that baseline outcome measures will be calculated and used to tailor the coach intervention. For example one of the measures, the Patient Activation Measure (18), assesses an individual's knowledge, skill and confidence in managing their health, and specifies the types of interventions to increase activation. This is important because a systematic review of evidence on the performance of the Patient Activation Measure conducted by the National Health Service in 2012 (19) found that: higher PAM scores were associated with increased patient participation, significantly better health and significantly lower rates of doctor office visits, emergency room visits, and hospital nights; healthy behaviours; improved adherence to treatment; and with better doctor-patient communication. The study is also using other outcome measures that enable the tailoring of the intervention, for example the medication adherence and health literacy measures.
The coach will work with the subject by telephone for six months. Coaches will help subjects gain the knowledge, skills, tools, and confidence they need to become active participants in their care so that they can reach their self-identified health goals. The coach will also assist the patient to participate in the Diabetes Self-Management Program, learn and use effective self-management strategies (i.e., action plans and problem solving); understand and follow their medication regimen; access community resources (e.g., recreation centre); and receive eligible federal and provincial mandated services (e.g., income assistance, disability benefits), and learn about and use community resources (e.g., recreation centres), and assist the patient to use mandated services (e.g., income assistance).
With respect to innovation, it is time to tap the (largely) untapped resource of peer support to deal with the burden of diabetes (20). According to the World Health Organization, patients and families are the most undervalued assets in the health care system (10). A potential solution is to train peers to " coach" or work collaboratively to deliver self-management support to persons with diabetes. Peer coaching is defined as " helping patients gain the knowledge, skills, tools, and confidence they need to become active participants in their care so that they can reach their self-identified health goals" (21). A peer coaching intervention complements, enhances, and increases the comprehensiveness of primary care services, while increasing patient centredness and reducing fragmentation of care (21). While family, caretakers, friends and healthcare professionals can fill the role of advisor, supporter and role model, they can rarely fulfill all three roles. Peer health coaches, however, can fulfill all three roles and also benefit personally. Utilizing peer advisors for chronic disease management and particularly for people with type 2 diabetes has the potential to be cost effective (22). In a systematic review of the literature on peer support for chronic and complex conditions, the authors found more evidence that peer self-management support was effective with socially disadvantaged groups. Improved health outcomes were found for a Bangladeshi and Maori community with culturally relevant peer support in diabetes programs (23).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Delta, British Columbia, Canada, V4K 2K6
- UVictoria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults, living in Fraser Health Region of British Columbia, type 2 diabetes, ability to speak English or Punjabi
Exclusion Criteria:
- Type 1 diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Diabetes health coach support
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.
|
Receives support from a trained peer health coach for a six month period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Activation Measure (PAM)
Time Frame: one year
|
This is a composite measure
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycated hemoglobin test (A1C)
Time Frame: one year
|
Measures blood glucose level
|
one year
|
Diabetes Empowerment Scale (DES)
Time Frame: one year
|
Assesses subjects' perception of empowerment to manage diabetes
|
one year
|
Self-efficacy
Time Frame: one year
|
Measures confidence in managing diabetes
|
one year
|
Self-reported health
Time Frame: one year
|
Assess subjects' perception of their health status
|
one year
|
Fatigue
Time Frame: one year
|
Assesses subjects' perception of fatigue level
|
one year
|
Pain
Time Frame: one year
|
Assesses subjects' perception of pain level
|
one year
|
Patient Health Questionnaire (PHQ-9) Depression Scale
Time Frame: one year
|
Assesses subjects' perception of depression experience
|
one year
|
Communication with physician
Time Frame: one year
|
Assesses' subjects' communication with their doctor
|
one year
|
Medication Adherence scale
Time Frame: one year
|
Measures subjects' adherence to prescribed medication
|
one year
|
Chow 3 question health literacy scale
Time Frame: one year
|
Measures health literacy
|
one year
|
Self-reported healthcare utilization
Time Frame: one year
|
Self-report number of doctor visits, emergency room visits, and nights in hospital
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick T McGowan, PhD, University of Victoria
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-775-Diabetes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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