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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Alberta Heritage Foundation for Medical Research
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT00789282
First received: May 12, 2008
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: multidisciplinary approach
Other: multifactorial approach - for enhanced care group
Other: reflects current patterns of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Single-blinded, Two-arm, Randomized Clinical Trial of Patients With Type 2 Diabetes Mellitus That Will Compare'Usual Care' With an 'Enhanced Care' Model of Chronic Disease Management That is Based in the Practices of Family Physicians Participating in Primary Care Networks (PCN's).

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: February 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care Group
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

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.

Experimental: Enhanced Care Group
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
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.
Other: multifactorial approach - for enhanced care group
optimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams

Detailed Description:

This is a single-blinded, two-arm, randomized clinical trial of patients with type 2 diabetes mellitus that will compare 'usual care' with an 'enhanced care' model of chronic disease management that is based in the practices of family physicians participating in Primary Care Networks (PCN's).

In this study, patients will be randomized into:

  1. Usual care (control) Will reflect current patterns of care for patients with type 2 diabetes in the Capital Health region.
  2. Enhanced Care (intervention) Will receive a multifactorial intervention with three main components that include:

    1. optimized medical management,
    2. support for development of enhanced patient self care management skills, and
    3. organized proactive follow-up by chronic disease management (CDM) teams to support improvements in care.

These components are key elements of the Chronic Care Model. They will be delivered by CDM teams working in the practices family physicians in the Primary Care Networks (PCN's).

Clinical Outcome Measures

  • will be assessed at baseline, 3 months, and 6 months.

Quality of Life Measures

  • will be measured at baseline, 6 months, and 12 months.

Risks and Benefits

The prevalence of diabetes mellitus is high and expected to increase in the future. It is unlikely that current systems of care will be adequate to provide care to patients with diabetes in the future. This study will evaluate a model of care of care , based on the Chronic Care Model, which has been provided to improve the care of patients with chronic diseases like diabetes. Patients may benefit due to improved care for their diabetes. Health care providers may benefit through an increased understanding of best methods and organization to provide care to populations of patients with diabetes and other chronic diseases.

Privacy and Confidentiality:

All study data collected will be kept confidential. Respondents will not be identified by name in any presentation or publications arising from the study. Access to data is restricted to investigators and project staff.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  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: NCT00789282

Locations
Canada, Alberta
University of Alberta, Dept of Family Medicicne Recruiting
Edmonton, Alberta, Canada, T6G - 2C8
Contact: Olga - Szafran, MHSA    (780) 492-4728    olga.szafran@ualberta.ca   
Principal Investigator: Neil - Bell, MD         
Sponsors and Collaborators
University of Alberta
Alberta Heritage Foundation for Medical Research
Investigators
Principal Investigator: Neil - Bell, MD,MSc,CCFP,FCFP Professor, Dept of Family Medicine, University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT00789282     History of Changes
Other Study ID Numbers: 200500865, UofA grant #: 20070388
Study First Received: May 12, 2008
Last Updated: November 23, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
chronic disease
Family Physician
primary care network
practice-based model
type 2 diabetes
complications
sequelae

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014