The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes

Study Overview
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Brief Summary
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The goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only.

Detailed Description
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In the current health care environment, it is unacceptable for patient education programs to merely provide information. Rather, educational programs must concentrate on behavior change and on supporting patients to become more confident and motivated in participating in managing their health. Persons with type 2 diabetes attending a Diabetes Education Centre will be assigned to either a group that receives regular professionally-led diabetes patient education (control group) or to to a group that receives regular professionally-led diabetes patient education augmented by lay-led self-management education i.e., the Stanford six-session Chronic Disease Self-Management Program (experimental group). Data will be collected at two points in time (0 and 6 months). Outcome measures will show if participants who receive self-management training in addition to regular patient education are able to:manage their diabetes more effectively; engage in the specific behaviors that keep the condition from worsening; achieve more control over their condition; and use the health care system more effectively.

Official Title
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The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Regular diabetes patient education
* Behavioral: Augmented diabetes patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults with type 2 diabetes Exclusion Criteria: cognitive impairment unable to speak English

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular diabetes patient education<br>Regular professionally-led diabetes patient education | Behavioral: Regular diabetes patient education<br>* Professionally-led diabetes patient education delivered by health professionals over a two day period<br>|
| Experimental: Augmented Diabetes Patient Education<br>Regular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program | Behavioral: Augmented diabetes patient education<br>* Professionally-led diabetes patient education led by nurse and dietitian over a two day period augmented by participation in the Stanford Chronic Disease Self-Management Program. This program takes place for 2 1/2 hours per week for six consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management behaviors |  | 6 months | 
| Self-efficacy levels |  | 6 months | 
| Health status |  | 6 months | 
| Cholesterol levels |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-efficacy, health behavior, patient education, health education