Clinical trial NCT00498147: Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program
Official title: Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disease Management
Diabetes Complications
Diabetic Vascular Complications
Diabetic Neuropathy
Diabetic Nephropathy
Diabetic Retinopathy
Keywords: amputation
angina
angiography
angioplasty
arterial disease
artery disease
bypass
CABG
cad
carotid
cerebral accident
CHF
CRF
CVA
endarterectomy
heart attack
heart failure
infarct
kidney disease
kidney failure
laser
nephropathy
neuropathy
pad
PCI
percutaneous coronary
percutaneous transluminal
pvd
renal failure
retinopathy
revascularization
schemia
stenosis
stent
stroke
transient
ulcer
vascular disease
Lead sponsor: Group Health Centre
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-07-09
Enrollment: 1213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patients of the Group Health Centre who are over the age of 18 years with a confirmed diagnosis of diabetes mellitus and who are enrolled in the Algoma Diabetes Education and Care (ADEC) program. ADEC is a managed diabetes care program and part of the Group Health Centre (GHC), a multi-specialty, interdisciplinary, ambulatory care facility located in Sault Ste. Marie, a northern Ontario community. With diagnostic services and a comprehensive electronic medical record, GHC provides health care to most of the community's population of approximately 75,000.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates
timeFrame: 1 year
Secondary outcomes:
measure: The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.
timeFrame: 1 year
Other outcomes:
Locations:
city: Sault Ste. Marie
country: Canada
facility: Group Health Centre
state: Ontario
Study officials:
affiliation: The Group Health Centre
name: Silvana Spadafora, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: