English Diabetes Self-Management Program
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|ClinicalTrials.gov Identifier: NCT00684086|
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 26, 2008
We propose a diabetes self-management program evaluation and dissemination project with three components.
- 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.
- A long-term (12 month) longitudinal evaluation of the same program.
- Two 5 day workshops to train others in California in how to lead and administer the program.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Diabetes Self Management Program||Not Applicable|
- 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.
- Evaluate the same program in a one year longitudinal study using the same outcomes.
- 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:
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).
- 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.
- Improvements in beneficial self-management behaviors (aerobic exercise, communication with physicians, diet, self-monitoring of blood glucose and self-examination of the feet).
- 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.)
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||English Diabetes Self-Management Program|
|Study Start Date :||April 2007|
- hemoglobin A1
- symptoms of hypoglycemia
- symptoms of hyperglycemia
- self-monitoring of blood glucose
- self-efficacy to manage diabetes
- physical discomfort
- activity limitations
- health distress
- self-rated health
- aerobic exercise
- communication with physicians
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684086
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Kate R Lorig||Stanford University|