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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Group Health Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Group Health Centre
ClinicalTrials.gov Identifier:
NCT00498147
First received: July 6, 2007
Last updated: October 5, 2009
Last verified: October 2009

July 6, 2007
October 5, 2009
July 2007
March 2010   (final data collection date for primary outcome measure)
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00498147 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program
Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?

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.

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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
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.

  • Disease Management
  • Diabetes Complications
  • Diabetic Vascular Complications
  • Diabetic Neuropathy
  • Diabetic Nephropathy
  • Diabetic Retinopathy
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 new to the ADEC program who will be provided the ADEC interventions (prospective study)
    Intervention: Other: ADEC Program
  • 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)
    Intervention: Other: ADEC Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1213
July 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00498147
DECIDE
No
Dr. Silvana Spadafora, Group Health Centre
Group Health Centre
Pfizer
Principal Investigator: Silvana Spadafora, MD FRCPC The Group Health Centre
Group Health Centre
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP