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Clinical Trials/NCT00498147
NCT00498147
Unknown
Not Applicable

Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?

Group Health Centre1 site in 1 country1,213 target enrollmentJuly 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disease Management
Sponsor
Group Health Centre
Enrollment
1213
Locations
1
Primary Endpoint
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates
Last Updated
16 years ago

Overview

Brief Summary

The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.

Detailed Description

The DECIDE study will identify whether cardiovascular complication rates (the composite rate of myocardial infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG), stroke, carotid endarterectomy, peripheral revascularization, and peripheral amputation) are lower in patients who participate in managed diabetes care by ADEC in comparison to provincial and national rates. Comparison statistics will be provided by the Institute of Evaluative Sciences (ICES) Atlas 2003 and other Diabetes studies such as the 2005 DICE study. Complications such as nephropathy and retinopathy will be documented, along with hospitalization rates and all cause mortality. Clinical outcomes relevant to diabetes management such as blood pressure and lipids will also be compared.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
July 2010
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Ambulatory patients over the age of 18 years with diabetes mellitus.
  • Current enrolment in ADEC program (\>6 months)or new enrolment in ADEC program (\<6 months).
  • Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines.
  • Informed consent provided

Exclusion Criteria

  • History of only gestational diabetes.
  • Non-GHC member.
  • GHC patients with diabetes who do not attend the ADEC program.
  • Unable to give informed consent.
  • Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program.
  • Refusal to allow research staff access to medical records, including hospital charts.

Outcomes

Primary Outcomes

Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates

Time Frame: 1 year

Secondary Outcomes

  • The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.(1 year)

Study Sites (1)

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