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

May 19, 2009 updated by: University of Victoria
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Delta, British Columbia, Canada, V4K 2K6
        • University of Victoria - Centre on Aging (Ladner Office), Suite 210, 4907 Chisholm Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults with type 2 diabetes

Exclusion Criteria:

  • cognitive impairment
  • unable to speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Regular diabetes patient education
Regular professionally-led diabetes patient education
Behavioral: Regular diabetes patient education
Professionally-led diabetes patient education delivered by health professionals over a two day period
Experimental: Augmented Diabetes Patient Education
Regular professionally-led diabetes patient education augmented by participation in the Stanford Chronic Disease Self-Management Program
Behavioral: Augmented diabetes patient education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A1C
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Victoria

Collaborators

Vancouver Foundation

Investigators

  • Principal Investigator: Patrick T McGowan, PhD, University of Victoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCM03-0095

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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