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Trial record 1 of 1 for:    NCT00498147
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Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program (DECIDE)

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ClinicalTrials.gov Identifier: NCT00498147
Recruitment Status : Unknown
Verified October 2009 by Group Health Centre.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2007
Last Update Posted : October 6, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
Group Health Centre

Tracking Information
First Submitted Date July 6, 2007
First Posted Date July 9, 2007
Last Update Posted Date October 6, 2009
Study Start Date July 2007
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2009)
Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates [ Time Frame: 1 year ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: October 5, 2009)
The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes. [ Time Frame: 1 year ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program
Official Title Does Managed Diabetes Care Decrease Cardiovascular Complications of Diabetes?
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Disease Management
  • Diabetes Complications
  • Diabetic Vascular Complications
  • Diabetic Neuropathy
  • Diabetic Nephropathy
  • Diabetic Retinopathy
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.
Other Name: Managed Diabetes Care
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: October 5, 2009)
1213
Original Estimated Enrollment
 (submitted: July 6, 2007)
1200
Estimated Study Completion Date July 2010
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00498147
Other Study ID Numbers DECIDE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Silvana Spadafora, Group Health Centre
Study Sponsor Group Health Centre
Collaborators Pfizer
Investigators
Principal Investigator: Silvana Spadafora, MD FRCPC The Group Health Centre
PRS Account Group Health Centre
Verification Date October 2009