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

Diabetic Retinopathy Clinical Trial

— DECIDE  

Official title:

Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00498147
• Other study ID #: DECIDE
• Status: Active, not recruiting
• Phase: N/A
• First received: July 6, 2007
• Last updated: October 5, 2009
• Start date: July 2007
• Est. completion date: July 2010

Study information

• Verified date: October 2009
• Source: Group Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1213
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetic Angiopathies
• Diabetic Nephropathies
• Diabetic Nephropathy
• Diabetic Neuropathies
• Diabetic Neuropathy
• Diabetic Retinopathy
• Diabetic Vascular Complications
• Disease Management
• Kidney Diseases
• Retinal Diseases

Intervention

Other:
• ADEC Program
Interventions (managed diabetes care) employed by the ADEC Program include: diabetes education, nutrition care, individual and group counseling sessions, foot care, and insulin and oral diabetes medication adjustments with a signed medical directive. ADEC Diabetes Educators (Registered Dietitians and Registered Nurses) will use adult education principles throughout the education process and promote self-care by encouraging responsibility and promoting a positive attitude towards acceptance of diabetes. All patients will be encouraged to self-monitor their blood glucose at home. Team member collaboration and with other agencies to promote a total client care approach to diabetes management will be employed.

Locations

Country	Name	City	State
Canada	Group Health Centre	Sault Ste. Marie	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Group Health Centre	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates		1 year	No
Secondary	The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.		1 year	No

External Links

•   Group Health Centre website