Clinical trial NCT00220207: Determining the Effect on Patients of Internet-Based Diabetes Disease Management
Official title: A Randomized Controlled Trial of Diabetes Disease Management Over the Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Health Education
Information Technology
African Americans
Disease Management
Internet
Patient Education
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* African American

Exclusion Criteria:

* non-English speaking

Primary outcomes:
measure: Hemoglobin A1c
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Harold I. Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: