Determining Rates of Cardiovascular Complications Among...

Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program (DECIDE)

Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program (DECIDE)
ClinicalTrials.gov

This study is currently recruiting participants.
Verified by Group Health Centre, October 2007

Sponsors and Collaborators: Group Health Centre, Pfizer
Information provided by: Group Health Centre
ClinicalTrials.gov Identifier: NCT00498147

Purpose
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.

Condition
Disease Management
Diabetes Complications
Diabetic Vascular Complications
Diabetic Neuropathies

Study Type: Observational
Study Design: Natural History, Cross-Sectional, Convenience Sample, Retrospective/Prospective Study
Official Title: Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?

Further study details as provided by Group Health Centre:

Estimated Enrollment: 1200
Study Start Date: July 2007
Estimated Study Completion Date: June 2008

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 hospitilization rates and all cause mortality. Clinical outcomes relevant to diabetes management such as blood pressure and lipids will also be compared.

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
1. Ambulatory patients over the age of 18 years with diabetes mellitus.
2. Current enrolment in ADEC program (more than 6 months)or new enrolment in ADEC program (less than 6 months).
3. Confirmed diagnosis of diabetes, 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/circumstance that prevents the patient from attending ADEC sessions or to participate fully in the program.
6. Refusal to allow research staff access to medical records, including hospital charts.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498147

Contacts
Contact: David Crookston, MD 705-759-1234 crookston_d@ghc.on.ca
Contact: Sharon Cuddy, BSc 705-759-1234 ext 2292 cuddy_s@ghc.on.ca

Locations
Canada, Ontario
Group Health Centre Recruiting
Sault Ste. Marie, Ontario, Canada, P6A 1Y7
Contact: Sharon Cuddy, BSc 705-759-1234 ext 2292 cuddy_s@ghc.on.ca
Contact: Elaine Blakeborough, BSc, MBA 705-759-1234 ext 2207 blakeborough_e@ghc.on.ca

Sponsors and Collaborators
Group Health Centre
Pfizer

Investigators
Principal Investigator: David Crookston, MD The Group Health Centre

More Information

Group Health Centre website This link exits the ClinicalTrials.gov site

Study ID Numbers: DECIDE
First Received: July 6, 2007
Last Updated: October 5, 2007
ClinicalTrials.gov Identifier: NCT00498147
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Metabolic Diseases
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Vascular Diseases
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications
Diabetic Angiopathies

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 04, 2008