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

This study has been completed.
Sponsor:
Information provided by:
Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:
NCT00220207
First received: September 15, 2005
Last updated: July 31, 2007
Last verified: July 2007

September 15, 2005
July 31, 2007
September 2003
Not Provided
Hemoglobin A1c
Same as current
Complete list of historical versions of study NCT00220207 on ClinicalTrials.gov Archive Site
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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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Behavioral: Internet co-management module
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
February 2007
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Inclusion Criteria:

  • African American

Exclusion Criteria:

  • non-English speaking
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00220207
49154
No
Not Provided
Robert Wood Johnson Foundation
Not Provided
Principal Investigator: Harold I. Goldberg, MD University of Washington
Robert Wood Johnson Foundation
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP