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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet co-management module
Sponsored by
Robert Wood Johnson Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Health Education, Information Technology, African Americans, Disease Management, Internet, Patient Education

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harborview Medical Center

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Secondary Outcome Measures

Full Information

First Posted
September 15, 2005
Last Updated
July 31, 2007
Sponsor
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00220207
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Health Education, Information Technology, African Americans, Disease Management, Internet, Patient Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Internet co-management module
Primary Outcome Measure Information:
Title
Hemoglobin A1c

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: African American Exclusion Criteria: non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold I. Goldberg, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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