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).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
时间窗: 1 year
次要结局
- 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)