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

A Randomized Controlled Trial of Diabetes Disease Management Over the Internet

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00220207
Enrollment
63
Registered
2005-09-22
Start date
2003-09-30
Completion date
2007-02-28
Last updated
2007-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes, Health Education, Information Technology, African Americans, Disease Management, Internet, Patient Education

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.

Interventions

Sponsors

Robert Wood Johnson Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* African American

Exclusion criteria

* non-English speaking

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1c

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026