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

NCT00498147 | Unknown

• 1 other identifier: DECIDE
• Study Type: observational
• Target: 1,213
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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; revascularization; schemia; stenosis; stent; stroke; transient; ulcer; vascular disease

Outcome Measures

Primary Outcomes (1)

• Rates of cardiovascular events and other complications of diabetes compared to provincial and national rates

  1 year

Secondary Outcomes (1)

• The secondary outcomes will be total mortality, CV- related events, and other selected complications of diabetes.

  1 year

Study Arms (2)

ADEC <6months

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

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)

Other: ADEC Program

Interventions

ADEC Program 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.

Also known as: Managed Diabetes Care

ADEC <6months; ADEC >6months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Group Health Centre: lead
• Pfizer: collaborator

Study Sites (1)

Group Health Centre

Sault Ste. Marie, Ontario, P6A 1Y7, Canada

Location

Related Links

• Group Health Centre website

MeSH Terms

Conditions

Diabetes Complications; Diabetic Angiopathies; Diabetic Neuropathies; Diabetic Nephropathies; Diabetic Retinopathy; Angina Pectoris; Coronary Artery Disease; Stroke; Myocardial Infarction; Heart Failure; Infarction; Kidney Diseases; Renal Insufficiency; Peripheral Vascular Diseases; Retinal Diseases; Constriction, Pathologic; Ulcer; Vascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Cardiovascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Eye Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Ischemia; Pathologic Processes; Necrosis; Pathological Conditions, Anatomical

Study Officials

• Silvana Spadafora, MD FRCPC

  The Group Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 6, 2009

Record last verified: 2009-10

Locations

CA (1)