Clinical trial NCT00684086: English Diabetes Self-Management Program
Official title: English Diabetes Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

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 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.

Primary outcomes:
measure: hemoglobin A1
measure: symptoms of hypoglycemia
measure: symptoms of hyperglycemia
measure: self-monitoring of blood glucose
measure: self-efficacy to manage diabetes
Secondary outcomes:
measure: fatigue
measure: physical discomfort
measure: activity limitations
measure: health distress
measure: self-rated health
measure: aerobic exercise
measure: communication with physicians
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kate R Lorig
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ. 2009 Jul-Aug;35(4):641-51. doi: 10.1177/0145721709335006. Epub 2009 Apr 30.