A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

Diabetes Clinical Trial

— COMPETEII  

Official title:

A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813085
• Other study ID #: 02-2068
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: December 19, 2008
• Start date: April 2002
• Est. completion date: December 2003

Study information

• Verified date: December 2008
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: December 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult, cognitively intact, consenting people with diabetes within enrolled practices

Exclusion Criteria:

• Non-english speaking

• Cognitively impaired

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Electronic disease management decision support
A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare & Mcmaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Health Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of change in diabetes quality of care between intervention and usual care group.		6 months follow-up	No
Secondary	Change in diabetes risk factor variables, satisfaction with care and technology, quality of life and health care utilization, health data privacy issues.		6 months	No