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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Diabetes Disease Management Over the Internet

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American

Exclusion Criteria:

  • non-English speaking
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00220207     History of Changes
Other Study ID Numbers: 49154
Study First Received: September 15, 2005
Last Updated: July 31, 2007
Health Authority: United States: Institutional Review Board

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014