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

Tracking Information

First Received Date ^ICMJE

December 18, 2008

Last Updated Date

December 19, 2008

Start Date ^ICMJE

April 2002

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of change in diabetes quality of care between intervention and usual care group. [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00813085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in diabetes risk factor variables, satisfaction with care and technology, quality of life and health care utilization, health data privacy issues. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Other: Electronic disease management decision support

Study Arms / Comparison Groups

Other: An electronic Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS).
No Intervention: Usual care by Family Physician

Publications *

Holbrook A, Thabane L, Keshavjee K, Dolovich L, Bernstein B, Chan D, Troyan S, Foster G, Gerstein H; COMPETE II Investigators. Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial. CMAJ. 2009 Jul 7;181(1-2):37-44.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

511

Completion Date

December 2003

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Non-english speaking
Cognitively impaired

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00813085

Responsible Party

Anne M Holbrook, PharmD, MD, MSc, St Joseph's Healthcare

Study ID Numbers ^ICMJE

02-2068

Study Sponsor ^ICMJE

McMaster University

Collaborators ^ICMJE

Health, Canada

Investigators ^ICMJE

Principal Investigator:

Anne M Holbrook, MD,PharmD,MSc

McMaster University

Information Provided By

McMaster University

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP