Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet co-management module
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Health Education, Information Technology, Disease Management, Internet, Patient Education
Eligibility Criteria
Inclusion Criteria: computer and Internet access at home receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt Exclusion Criteria: non-English speaking
Sites / Locations
- University of Washington, General Internal Medicine Clinic, Roosevelt
Outcomes
Primary Outcome Measures
Hemoglobin A1c
Secondary Outcome Measures
Utilization
Full Information
NCT ID
NCT00194506
First Posted
September 12, 2005
Last Updated
April 12, 2006
Sponsor
University of Washington
Collaborators
Center for Health Management Research
1. Study Identification
Unique Protocol Identification Number
NCT00194506
Brief Title
Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Official Title
Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Center for Health Management Research
4. Oversight
5. Study Description
Brief Summary
This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.
Detailed Description
We will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (DM) disease-management module (known as Cyber-DM) can improve the quality of adult diabetes care. The module will be Web-based, include a graphical HTML "front end" user interface, and will be incorporated into each patient's existing Web-based electronic medical record --the Medical Information Networked Database (MIND) repository at the University of Washington Academic Medical Centers. This Web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers:
An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.
Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.
An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.
The ability to download glucometer readings and medication-use information from home directly into the MIND repository.
Secure email communication between patients, their primary care physicians, and clinic staff.
A total of 80-85 diabetic patients who are regular utilizers of the UW's General Internal Medicine Clinic and who have home Internet access will be randomized to the experimental and control arms of the trial. Control subjects will receive usual care. We hypothesize that use of Cyber-DM will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. A trial this size would have the statistical power to detect a change in HbA1c of 0.50%. Secure Socket Layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.
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, Disease Management, Internet, Patient Education
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Internet co-management module
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Secondary Outcome Measure Information:
Title
Utilization
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:
computer and Internet access at home
receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt
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
University of Washington, General Internal Medicine Clinic, Roosevelt
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19017773
Citation
Ralston JD, Hirsch IB, Hoath J, Mullen M, Cheadle A, Goldberg HI. Web-based collaborative care for type 2 diabetes: a pilot randomized trial. Diabetes Care. 2009 Feb;32(2):234-9. doi: 10.2337/dc08-1220. Epub 2008 Nov 18.
Results Reference
derived
Learn more about this trial
Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
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