English Diabetes Self-Management Program

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00684086
First received: May 22, 2008
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

We propose a diabetes self-management program evaluation and dissemination project with three components.

  1. A six-month randomized trial to evaluate the effect of a community-based small group Diabetes Self Management Program (DSMP) on the health related quality of life, metabolic control and health care utilization of people with type 2 diabetes.
  2. A long-term (12 month) longitudinal evaluation of the same program.
  3. Two 5 day workshops to train others in California in how to lead and administer the program.

Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Diabetes Self Management Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: English Diabetes Self-Management Program

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • hemoglobin A1
  • symptoms of hypoglycemia
  • symptoms of hyperglycemia
  • self-monitoring of blood glucose
  • self-efficacy to manage diabetes

Secondary Outcome Measures:
  • fatigue
  • physical discomfort
  • activity limitations
  • health distress
  • self-rated health
  • aerobic exercise
  • communication with physicians

Estimated Enrollment: 350
Study Start Date: April 2007
Detailed Description:
  1. Implement and evaluate in a 6-month randomized controlled evaluation an experimental self-management program for patients with type 2 diabetes. Outcomes for evaluating the intervention's impact include health status (health-related quality-of-life and metabolic control) and health care utilization. Mediating outcomes are health behaviors and self-efficacy.
  2. Evaluate the same program in a one year longitudinal study using the same outcomes.
  3. Disseminate the program to others in California by holding two five day workshops during which we will prepare the participants to both offer the program and to train others in their organization to offer the program.

This proposed evaluation will examine the following questions:

Hypothesis 1. People participating in the Diabetes Self-Management Program (SDSMP), when compared six months after baseline to randomized wait-list controls receiving usual care, will demonstrate:

  1. Improvements in health-related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health).

    Improvements in metabolic measures of health status (body mass index, hemoglobin A1c, total cholesterol/HDL ratio and blood pressure).

  2. Changes in utilization of health services, specifically, increases in outpatient visits to physicians and nurses, increases in the percentage of subjects having received an eye examination in the past year, increases in the number of times a health professional has examined subject's feet, and decreases in emergency room visits, hospitalizations, and hospital days.
  3. Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet).
  4. Increases in perceived self-efficacy to manage diabetes.

Hypothesis 2. The changes in health related quality of life, metabolic status, health behaviors and health care utilization will be maintained for one year.

Hypothesis 3. Twelve to fifteen health care organizations in California will be interested in disseminating the program. This will be demonstrated by their willingness to send 2-3 persons each to a 5 day training which will allow their organization to replicate and perpetuate the program.

Hypothesis 4. 8-10 health care organizations in California will have offered at least two Diabetes Self-Management Programs to people with Type 2 diabetes one year following the above dissemination training. (It should be noted that this hypothesis can not be tested during the funded portion of the program. However, it our intent to contact all organizations participating in dissemination training one year following the training to determine what they have done with the program). The results of this follow-up will be reported to The Foundation.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with prior diagnosis of type 2 Diabetes.
  • Able to speak and comprehend English.
  • Able to give and complete consent forms.
  • Able to complete baseline questionnaire and 2-3 follow-up questionnaires either in writing or by telephone.
  • Able to attend respective community meetings or allow study staff to collect the following metabolic test measures: provide 3 drops of blood for Hemoglobin A1c and cholesterol HDL test (administered by subject), blood pressure measure, height and weight measures.
  • Able to attend the Peer-Led Community-Based Diabetes Self-Management Program workshops offered once a week for six weeks at a community site near subjects residence.

Exclusion Criteria:

  • Individuals not diagnosed with type 2 diabetes.
  • Individuals diagnosed with type 1 diabetes.
  • Pregnant women, including those diagnosed with gestational diabetes.
  • Individuals who have been in active treatment for cancer in the past yar.
  • Individuals not able to speak or comprehend English.
  • Individuals who are currently or have previously participated in a similar program or study.
  • Individuals that are not able to give consent or complete consent forms, and other study related forms such as questionnaires.
  • Individuals who are not able and willing to provide metabolic test data.
  • Individuals not able to attend the 6-week community classes in the target counties in California.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684086

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kate R Lorig Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00684086     History of Changes
Other Study ID Numbers: 96943, 5312
Study First Received: May 22, 2008
Last Updated: May 23, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014