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

NCT ID: NCT00498147

Last Updated: 2009-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Disease Management Diabetes Complications Diabetic Vascular Complications Diabetic Neuropathy Diabetic Nephropathy Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Groups

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ADEC <6months

Patients new to the ADEC program who will be provided the ADEC interventions (prospective study)

ADEC Program

Intervention Type OTHER

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.

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)

ADEC Program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Managed Diabetes Care

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Group Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Group Health Centre

Principal Investigators

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Silvana Spadafora, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

The Group Health Centre

Locations

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Group Health Centre

Sault Ste. Marie, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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http://www.ghc.on.ca

Group Health Centre website

Other Identifiers

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DECIDE

Identifier Type: -

Identifier Source: org_study_id

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