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Completed

NCT Number: NCT00220207

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • African American

Exclusion criteria

  • non-English speaking

Treatment and study plan

Internet co-management module

Behavioral

Primary outcomes

  1. Hemoglobin A1c

Sponsors and collaborators

Lead sponsor

Robert Wood Johnson Foundation

Other

Registry information

Official study title

A Randomized Controlled Trial of Diabetes Disease Management Over the Internet

Important dates

Study start
2003
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Aug 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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