Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Vancouver Foundation
Information provided by:
University of Victoria
ClinicalTrials.gov Identifier:
NCT00906919
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
 Behavioral: Regular diabetes patient education
Behavioral: Augmented diabetes patient education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effectiveness of Diabetes Patient Education and Self-Management Education in Persons With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Victoria:

Primary Outcome Measures:
  • A1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-management behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self-efficacy levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cholesterol levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 321
Study Start Date: April 2004
Study Completion Date: April 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults with type 2 diabetes

Exclusion Criteria:

  • cognitive impairment
  • unable to speak English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906919

Locations
Canada, British Columbia
University of Victoria - Centre on Aging (Ladner Office), Suite 210, 4907 Chisholm Street
Delta, British Columbia, Canada, V4K 2K6
Sponsors and Collaborators
University of Victoria
Vancouver Foundation
Investigators
Principal Investigator: Patrick T McGowan, PhD University of Victoria
  More Information

No publications provided

Responsible Party: Patrick McGowan, PhD, University of Victoria - Centre on Aging
ClinicalTrials.gov Identifier: NCT00906919     History of Changes
Other Study ID Numbers: BCM03-0095
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Victoria:
self-efficacy
health behavior
patient education
health education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013