- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00789282
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).
Study Overview
Status
Conditions
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:
- Usual care (control) Will reflect current patterns of care for patients with type 2 diabetes in the Capital Health region.
Enhanced Care (intervention) Will receive a multifactorial intervention with three main components that include:
- optimized medical management,
- support for development of enhanced patient self care management skills, and
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G - 2C8
- University of Alberta, Dept of Family Medicicne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
|
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.
optimized medical management support for development of enhanced patient self management skills organized proactive follow-up chronic disease management teams
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Neil Bell, MD,MSc,CCFP,FCFP, Professor, Dept of Family Medicine, University of Alberta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200500865
- UofA grant #: 20070388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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