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CompletedNCT00813085COMPETEIIUpdated Dec 22, 2008

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

An interventional study of Electronic disease management decision support in Diabetes, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-12-22.

Sponsored by McMaster University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
511
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

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Keywords

  • Diabetes
  • Computerized clinical decision support
  • shared care
  • patient self-monitoring
  • quality of care
  • complex interventions
  • composite outcomes
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 511 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non-english speaking
  • Cognitively impaired
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
511 participants (actual)

Study arms

  • Other
    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).

    Other: Electronic disease management decision support

  • No intervention
    2

    Usual care by Family Physician

Interventions

  • OtherElectronic disease management decision support

    A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)

    Also known as: Intervention

06

What researchers measure

Primary outcomes

  1. Comparison of change in diabetes quality of care between intervention and usual care group.

    Time frame: 6 months follow-up

Secondary outcomes

  1. 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

07

Study locations

1 site
  • St Joseph's Healthcare & Mcmaster University
    Hamilton, Ontario, Canada
08

References and documents

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. doi: 10.1503/cmaj.081272. PubMed 19581618 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00813085
Collaborators
Health Canada
First posted
Dec 22, 2008
Start date
Apr 2002
Primary completion
Sep 2003
Completion
Dec 2003
Last update
Dec 22, 2008

Study contacts

Anne M Holbrook, MD,PharmD,MSc
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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