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Clinical Trials/NCT00220207
NCT00220207
Completed
Not Applicable

A Randomized Controlled Trial of Diabetes Disease Management Over the Internet

Robert Wood Johnson Foundation1 site in 1 country63 target enrollmentSeptember 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Robert Wood Johnson Foundation
Enrollment
63
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

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

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: 1. View their entire electronic medical record, the same record used by providers, 2. Upload blood glucose readings stored in a digital meter, 3. Enter medication, nutrition, and exercise information into an online daily diary, 4. Communicate with providers regarding treatment recommendations or other questions using clinical e-mail, 5. Obtain additional information from a traditional patient education site with endorsed content, and 6. 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: 1. Determine the effect of case-managed, Web-based diabetes care on glycemic control, healthcare utilization, self-efficacy, and patient satisfaction, and 2. 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.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
February 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Robert Wood Johnson Foundation

Eligibility Criteria

Inclusion Criteria

  • African American

Exclusion Criteria

  • non-English speaking

Outcomes

Primary Outcomes

Hemoglobin A1c

Study Sites (1)

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