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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

This study has been terminated.
(Recruitment challenges.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789282
First Posted: November 11, 2008
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alberta Heritage Foundation for Medical Research
Information provided by (Responsible Party):
University of Alberta
May 12, 2008
November 11, 2008
May 19, 2017
February 2008
February 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00789282 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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).
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Diabetes Mellitus, Type 2
  • 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
  • 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.

  • 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
    Intervention: Other: reflects current patterns of care
  • 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.
    Interventions:
    • Other: multidisciplinary approach
    • Other: multifactorial approach - for enhanced care group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
December 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00789282
200500865
UofA grant #: 20070388
No
Not Provided
Not Provided
University of Alberta
University of Alberta
Alberta Heritage Foundation for Medical Research
Principal Investigator: Neil Bell, MD,MSc,CCFP,FCFP Professor, Dept of Family Medicine, University of Alberta
University of Alberta
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP