Text Size

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
  Purpose

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.


Condition Intervention
Diabetes
 Other: Electronic disease management decision support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 511
Study Start Date: April 2002
Study Completion Date: December 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)
Other Name: Intervention
No Intervention: 2
Usual care by Family Physician

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-english speaking
  • Cognitively impaired
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813085

Locations
Canada, Ontario
St Joseph's Healthcare & Mcmaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Health Canada
Investigators
Principal Investigator: Anne M Holbrook, MD,PharmD,MSc McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anne M Holbrook, PharmD, MD, MSc, St Joseph's Healthcare
ClinicalTrials.gov Identifier: NCT00813085     History of Changes
Other Study ID Numbers: 02-2068
Study First Received: December 18, 2008
Last Updated: December 19, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Diabetes
Computerized clinical decision support
shared care
patient self-monitoring
 quality of care
complex interventions
composite outcomes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013