Determining the Effect on Patients of Internet-Based Diabetes Disease Management

Study Overview
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Brief Summary
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This grant supports a 12-month randomized controlled trial comparing usual care versus collaborative disease management over the Internet among disadvantaged African-Americans with Type 2 diabetes. The project aims to: (1) determine the effect of case-managed, Web-based diabetes care on glycemic control, health care utilization, self-efficacy, and patient satisfaction; and (2) qualitatively identify enablers of the successful use of computers, the Internet, and e-Health applications by disadvantaged patients.

Detailed Description
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We propose to conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management over the Internet among disadvantaged African-Americans with type 2 diabetes. Subjects will be recruited from patients receiving primary care at Harborview Medical Center, the County facility administered by the University of Washington in Seattle. As part of a pretest-posttest experimental design, 30 intervention subjects will be trained to use an existing diabetes disease-management module comprising six Web sites that are accessed from home via links displayed within the University's MyUW Internet portal. These sites allow patients to: View their entire electronic medical record, the same record used by providers, Upload blood glucose readings stored in a digital meter, Enter medication, nutrition, and exercise information into an online daily diary, Communicate with providers regarding treatment recommendations or other questions using clinical e-mail, Obtain additional information from a traditional patient education site with endorsed content, and Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy. All data can be viewed by patients and providers in online trended displays that a clinical pharmacist will use to review cases no less often than weekly. As an attention control, 30 subjects will also be trained to use a provided personal computer to access Internet knowledge resources, but will not have access to the case-management services and module being evaluated. By comparing the two groups, we aim to: Determine the effect of case-managed, Web-based diabetes care on glycemic control, healthcare utilization, self-efficacy, and patient satisfaction, and Use semi-structured interviews among a subsample of both trial arms to qualitatively identify enablers of the successful use of computers, the Internet, and e-health applications by disadvantaged patients.

Official Title
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A Randomized Controlled Trial of Diabetes Disease Management Over the Internet

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Internet co-management module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American Exclusion Criteria: non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Internet co-management module|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Health Education, Information Technology, African Americans, Disease Management, Internet, Patient Education