Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194506
Status:
COMPLETED
Last Update Posted:
2006-04-14
First Post:
2005-09-12
Brief Title:
Cyber Disease Management Using the World Wide Web to Share the Medical Record With Patients at Home
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Cyber Disease Management Using the World Wide Web to Share the Medical Record With Patients at Home
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Washingtons 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 patients 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
1 An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials
2 Real-time clinical reminders of the need to obtain preventive services such as HbA1c urine-protein and cholesterol determinations and retinal examinations
3 An electronic version of the SDMTM diabetes-care algorithms indicating where on the road-map to adequate control they currently stand treatment-wise
4 The ability to download glucometer readings and medication-use information from home directly into the MIND repository
5 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 UWs 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 050 Secure Socket Layer technology session specific cookie files and a custom database application that manages loginspasswords and audits all accesses to the system will provide security for this information tool
1 An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials
2 Real-time clinical reminders of the need to obtain preventive services such as HbA1c urine-protein and cholesterol determinations and retinal examinations
3 An electronic version of the SDMTM diabetes-care algorithms indicating where on the road-map to adequate control they currently stand treatment-wise
4 The ability to download glucometer readings and medication-use information from home directly into the MIND repository
5 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 UWs 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 050 Secure Socket Layer technology session specific cookie files and a custom database application that manages loginspasswords and audits all accesses to the system will provide security for this information tool
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None