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| ID | Type | Description | Link |
|---|---|---|---|
| UofA grant #: 20070388 |
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Recruitment challenges.
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| Name | Class |
|---|---|
| Alberta Heritage Foundation for Medical Research | OTHER |
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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:
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:
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
Quality of Life Measures
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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. | 1 year |
| Measure | Description | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Bell, MD,MSc,CCFP,FCFP | Professor, Dept of Family Medicine, University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta, Dept of Family Medicicne | Edmonton | Alberta | T6G - 2C8 | Canada |
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| 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 |
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| 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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