Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program (DECIDE)
Recruitment status was Active, not recruiting
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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 | Intervention |
|---|---|
|
Disease Management Diabetes Complications Diabetic Vascular Complications Diabetic Neuropathy Diabetic Nephropathy Diabetic Retinopathy |
Other: ADEC Program |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes? |
- Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 1213 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
ADEC <6months
Patients new to the ADEC program who will be provided the ADEC interventions (prospective study)
|
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.
Other Name: Managed Diabetes Care
|
|
ADEC >6months
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)
|
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.
Other Name: Managed Diabetes Care
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Ambulatory patients over the age of 18 years with diabetes mellitus.
- Current enrolment in ADEC program (>6 months)or new enrolment in ADEC program (<6 months).
- Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines.
- Informed consent provided
Exclusion Criteria:
- History of only gestational diabetes.
- Non-GHC member.
- GHC patients with diabetes who do not attend the ADEC program.
- Unable to give informed consent.
- Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program.
- Refusal to allow research staff access to medical records, including hospital charts.
Contacts and Locations| Canada, Ontario | |
| Group Health Centre | |
| Sault Ste. Marie, Ontario, Canada, P6A 1Y7 | |
| Principal Investigator: | Silvana Spadafora, MD FRCPC | The Group Health Centre |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Silvana Spadafora, Group Health Centre |
| ClinicalTrials.gov Identifier: | NCT00498147 History of Changes |
| Other Study ID Numbers: | DECIDE |
| Study First Received: | July 6, 2007 |
| Last Updated: | October 5, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Group Health Centre:
|
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 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetic Angiopathies Diabetic Nephropathies Diabetic Neuropathies Diabetic Retinopathy Kidney Diseases Retinal Diseases Diabetes Complications Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Urologic Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 17, 2013