Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Internet Diabetes Self-Management Evaluation
| Verified date | April 2013 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to determine of the effectiveness of an Internet based Diabetes
Self-Management workshop for people with type II diabetes. Half of the people who complete
the workshop will be invited to continue their education by participating in a email
discussion group. Thus, we will be able to learn both the efficacy of the original program
as well as its efficacy when reinforced by the discussion group.
Diabetes is a disease that must be managed day by day by the individual with the disease.
Although we know a great deal about the self-management of type II diabetes, most
self-management is less than optimal. In addition, most people with diabetes do not have an
opportunity to participate in formal diabetes education. This study will determine if an
Internet delivered educational workshop will help people with diabetes manage their disease.
Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c,
blood pressure, cholesterol, and weight. If successful the workshop will serve as a
prototype for Internet diabetes education.
| Status | Completed |
| Enrollment | 761 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria::- Diabetes type 2 - Have internet access and email address - Live in the United States - 18 years of age or older Exclusion Criteria:- Previous participation in similar online or community-based self-management program - Active treatment for cancer - Pregnant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University School of Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | 6 and 12 months | No | |
| Secondary | Outcome Measure: Health-related quality of life | 6 and 12 months | No | |
| Secondary | Outcome Measure: Health behaviors | 6 and 12 months | No | |
| Secondary | Health care utilization | 6 and 12 months | No |
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