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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:
ClinicalTrials.gov Identifier:
NCT00813085
First Posted: December 22, 2008
Last Update Posted: December 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Health Canada
Information provided by:
McMaster University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Submitted: December 18, 2008
First Posted: December 22, 2008
Last Update Posted: December 22, 2008
Last Verified: December 2008

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