English Diabetes Self-Management Program

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

English Diabetes Self-Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684086
• Other study ID #: 96943
• Secondary ID: 5312
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: May 23, 2008
• Start date: April 2007

Study information

• Verified date: May 2008
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes Self Management Program

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1
Primary	symptoms of hypoglycemia
Primary	symptoms of hyperglycemia
Primary	self-monitoring of blood glucose
Primary	self-efficacy to manage diabetes
Secondary	fatigue
Secondary	physical discomfort
Secondary	activity limitations
Secondary	health distress
Secondary	self-rated health
Secondary	aerobic exercise
Secondary	communication with physicians