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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220207
First Posted: September 22, 2005
Last Update Posted: August 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Robert Wood Johnson Foundation
  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.

Condition Intervention
Diabetes Mellitus, Type 2 Behavioral: Internet co-management module

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Diabetes Disease Management Over the Internet

Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:
  • Hemoglobin A1c

Estimated Enrollment: 63
Study Start Date: September 2003
Estimated Study Completion Date: February 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American

Exclusion Criteria:

  • non-English speaking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220207


Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Harold I. Goldberg, MD University of Washington
  More Information

ClinicalTrials.gov Identifier: NCT00220207     History of Changes
Other Study ID Numbers: 49154
First Submitted: September 15, 2005
First Posted: September 22, 2005
Last Update Posted: August 1, 2007
Last Verified: July 2007

Keywords provided by Robert Wood Johnson Foundation:
Diabetes
Health Education
Information Technology
African Americans
Disease Management
Internet
Patient Education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases