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

• Conditions: Disease Management; Diabetes Complications; Diabetic Vascular Complications; Diabetic Neuropathy; Diabetic Nephropathy; Diabetic Retinopathy
• Interventions: Other: ADEC Program

• Registration Number: NCT00498147
• Lead Sponsor: Group Health Centre

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-05
• Last Update Posted: 2009-10-06
• Primary Completion: 2010-03
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1213

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADEC <6months	ADEC Program	Patients new to the ADEC program who will be provided the ADEC interventions (prospective study)
ADEC >6months	ADEC Program	Patients who have been with the ADEC program as early as 2002 (coincides with ADEC's EMR initiation date) who continue to be provided the ADEC interventions (combined retrospective/prospective study)

Primary Outcome Measures

Name	Time	Method
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates	1 year

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.	1 year

Trial Locations

Locations (1)

Group Health Centre; 🇨🇦 Sault Ste. Marie, Ontario, Canada