Overview

This trial is active, not recruiting.

Conditions disease management, diabetes complications, diabetic vascular complications, diabetic neuropathy, diabetic nephropathy, diabetic retinopathy
Treatment adec program
Sponsor Group Health Centre
Collaborator Pfizer
Start date July 2007
End date March 2010
Trial size 1213 participants
Trial identifier NCT00498147, DECIDE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Patients new to the ADEC program who will be provided the ADEC interventions (prospective study)
adec program Managed Diabetes Care
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.
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)
adec program Managed Diabetes Care
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.

Primary Outcomes

Measure
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates
time frame: 1 year

Secondary Outcomes

Measure
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.
time frame: 1 year

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Group Health Centre.