Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program
This trial is active, not recruiting.
|Conditions||disease management, diabetes complications, diabetic vascular complications, diabetic neuropathy, diabetic nephropathy, diabetic retinopathy|
|Sponsor||Group Health Centre|
|Start date||July 2007|
|End date||March 2010|
|Trial size||1213 participants|
|Trial identifier||NCT00498147, DECIDE|
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.
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates
time frame: 1 year
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Ambulatory patients over the age of 18 years with diabetes mellitus. 2. Current enrolment in ADEC program (>6 months)or new enrolment in ADEC program (<6 months). 3. Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines. 4. Informed consent provided Exclusion Criteria: 1. History of only gestational diabetes. 2. Non-GHC member. 3. GHC patients with diabetes who do not attend the ADEC program. 4. Unable to give informed consent. 5. Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program. 6. Refusal to allow research staff access to medical records, including hospital charts.
|Official title||Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?|
|Principal investigator||Silvana Spadafora, MD FRCPC|
|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.|
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