Back to resultsThe Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Regular diabetes patient education
Augmented diabetes patient education
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring self-efficacy, health behavior, patient education, health education
Eligibility Criteria
Inclusion Criteria:
- adults with type 2 diabetes
Exclusion Criteria:
- cognitive impairment
- unable to speak English
Sites / Locations
- University of Victoria - Centre on Aging (Ladner Office), Suite 210, 4907 Chisholm Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Regular diabetes patient education
Augmented Diabetes Patient Education
Arm Description
Regular professionally-led diabetes patient education
Regular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program
Outcomes
Primary Outcome Measures
A1C
Secondary Outcome Measures
Self-management behaviors
Self-efficacy levels
Health status
Cholesterol levels
Full Information
NCT ID
NCT00906919
First Posted
May 19, 2009
Last Updated
May 19, 2009
Sponsor
University of Victoria
Collaborators
Vancouver Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00906919
Brief Title
The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes
Official Title
The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Victoria
Collaborators
Vancouver Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
self-efficacy, health behavior, patient education, health education
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular diabetes patient education
Arm Type
Active Comparator
Arm Description
Regular professionally-led diabetes patient education
Arm Title
Augmented Diabetes Patient Education
Arm Type
Experimental
Arm Description
Regular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program
Intervention Type
Behavioral
Intervention Name(s)
Regular diabetes patient education
Intervention Description
Professionally-led diabetes patient education delivered by health professionals over a two day period
Intervention Type
Behavioral
Intervention Name(s)
Augmented diabetes patient education
Intervention Description
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.
Primary Outcome Measure Information:
Title
A1C
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-management behaviors
Time Frame
6 months
Title
Self-efficacy levels
Time Frame
6 months
Title
Health status
Time Frame
6 months
Title
Cholesterol levels
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with type 2 diabetes
Exclusion Criteria:
cognitive impairment
unable to speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick T McGowan, PhD
Organizational Affiliation
University of Victoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Victoria - Centre on Aging (Ladner Office), Suite 210, 4907 Chisholm Street
City
Delta
State/Province
British Columbia
ZIP/Postal Code
V4K 2K6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes
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