Trial record 5 of 543 for:    "Diabetic Angiopathies"

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
  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?

Resource links provided by NLM:


Further study details as provided by Group Health Centre:

Primary Outcome Measures:
  • Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498147

Locations
Canada, Ontario
Group Health Centre
Sault Ste. Marie, Ontario, Canada, P6A 1Y7
Sponsors and Collaborators
Group Health Centre
Pfizer
Investigators
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:
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Diabetic Nephropathies
Diabetic Neuropathies
Diabetic Retinopathy
Kidney Diseases
Retinal Diseases
Cardiovascular Diseases
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014