Expired Study
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Seattle, Washington 98104


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

49154


NCT ID:

NCT00220207


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Randomized Controlled Trial of Diabetes Disease Management Over the Internet


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Robert Wood Johnson Foundation


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

63


Enrollment Type:


Overall Contact Information

Official Name:Harold I. Goldberg, MD
Principal Investigator
University of Washington

Study Dates

Start Date:September 2003
Completion Date:February 2007
Verification Date:July 2007
Last Changed Date:July 31, 2007
First Received Date:September 15, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Hemoglobin A1c
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Internet co-management module

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Robert Wood Johnson Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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