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

This study has been completed.
Sponsor:
Collaborator:
Health Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00813085
First received: December 18, 2008
Last updated: December 19, 2008
Last verified: December 2008
History of Changes

December 18, 2008
December 19, 2008
April 2002
September 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00813085 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Diabetes
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)
Other Name: Intervention
  • Electronic disease management decision support
    An electronic Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS).
    Intervention: Other: Electronic disease management decision support
  • No Intervention: 2
    Usual care by Family Physician
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
December 2003
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-english speaking
  • Cognitively impaired
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00813085
02-2068
No
Anne M Holbrook, PharmD, MD, MSc, St Joseph's Healthcare
McMaster University
Health Canada
Principal Investigator: Anne M Holbrook, MD,PharmD,MSc McMaster University
McMaster University
December 2008

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