Improving the Care of Diabetic Patients: A Randomized Trial of a Family Physician Office-Based Chronic Disease Care Model for Patients With Type 2 Diabetes

NCT00789282 | Terminated

• 2 other identifiers: 200500865UofA grant #: 20070388
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the efficacy of a family physician practice-based model of chronic disease management (CDM) based in Primary Care Networks (PCN's) that is integrated with the Capital Health Regional Diabetes Program for care of patients with type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

chronic disease; Family Physician; primary care network; practice-based model; type 2 diabetes; complications; sequelae

Outcome Measures

Primary Outcomes (1)

• A higher proportion of patients with type 2 diabetes enrolled in the 'enhanced care' arm compared with the patients enrolled 'usual' care' arm will achieve an absolute reduction in their HbaA1c of 1.0% or greater during the study period.

  1 year

Secondary Outcomes (1)

• A higher proportion of patients with type 2 diabetes in the 'enhanced care' arm compared with the patients enrolled in 'usual care' arm will achieve a 10% or greater reduction in HbA1c values during the study period.

  1 year

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

The 'usual care' study arm (control) will reflect current patterns of care for patients with thpe 2 diabetes in the Capital Health region

Other: reflects current patterns of care

Enhanced Care Group

EXPERIMENTAL

In the enhanced care group(intervention arm) the participants will receive a multifactorial intervention with three main components that include: optimized medical management, 2) support for development of enhanced patient self management skills, and 3) organized proactive follow-up by chronic disease management teams to support improvement in care.

Other: multidisciplinary approach; Other: multifactorial approach - for enhanced care group

Interventions

multidisciplinary approach OTHER

Provides an integrated, proactive approach to the management of patients with chronic diseases (ie: diabetes and sequelae) Wagner Model- care encompassed in 3 overlapping galaxies: wider community; the health care system; and the provider organization. There are 6 essential elements: community resources and policies; health care organization; patient self-management support; delivery system design; decision support; and clinical information systems.

Enhanced Care Group

multifactorial approach - for enhanced care group OTHER

optimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams

Enhanced Care Group

reflects current patterns of care OTHER

Continue under the care of their family physician and specialists with referral to diabetic assessment and treatment centers at the discretion of the patient and physician. Normal manner of care: could attend diabetic self education classes and consultations regarding management of diabetes. Or, participate in other patient self management program of their choice.

Usual Care Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes (2003 classification by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus) receiving any therapy with HbA1c of \> or = 7.0% between the ages of 40 - 75 years.

You may not qualify if:

• Type 1 diabetes
• Pregnancy
• Severe diabetic complications that include end stage renal disease requiring dialysis
• Proliferative retinopathy (growth of new vessels on the retina and posterior surface of the vitreous that requires laser therapy)
• Uncontrolled cardiovascular disease (CVS event within 1 year of enrollment)
• Psychiatric disease or cognitive impairment that would interfere with treatment compliance
• Cancer or terminally ill patients with less than 6 months life expectancy
• Blindness
• Other severe co- morbid diseases
• Participation in another intense multifactorial intervention for the management of type 2 diabetes
• Participation in another study

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Heritage Foundation for Medical Research: collaborator

Study Sites (1)

University of Alberta, Dept of Family Medicicne

Edmonton, Alberta, T6G - 2C8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Bell, MD,MSc,CCFP,FCFP

  Professor, Dept of Family Medicine, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: November 11, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 19, 2017

Record last verified: 2016-04

Locations

CA (1)