Disease Management Program (DMP) Stroke Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Framingham Risk Score: general cardiovascular disease 10 year risk
研究概览
简要总结
It has been reported that stroke is the first cause of becoming bedridden, and its cumulative recurrence rate in 5 years is approximately 35%. There is a high probability that patients reduce or discontinue medications by self-determination, leading to a high risk of stroke recurrence in these patients. Comprehensive and long-term patient educations ameliorating their self-management are important making patients possible to be managed according to the guidelines for their risk factors. Using disease management programs created for each of risk factors according to clinical practice guidelines, the influence of those programs were evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke Trial.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke onset [including transient ischemic attack (TIA)].
- •Receiving regular consultation with their primary care physician.
- •modified Rankin Scale (mRS) score from 0 to 3 at discharge.
排除标准
- •modified Rankin Scale (mRS) score 4 and over at discharge .
- •Patient having severe complications and the physical symptom that the contents of the program cannot carry out.
- •They had medical care in medical/nursing care institutions.
- •Patients with pregnancy or under terminal care.
- •Dementia (scores of ≤20/30 on the Revised Hasegawa's Dementia Scale) However, when a care-giving family member living with the patient could provide self-management, patients were included even if they had dementia.
研究组 & 干预措施
usual care
usual care group receive regular outpatient treatment
干预措施: usual care (Other)
disease management
desease management program include self management education by nurse on 6months.
干预措施: disease management (Other)
disease management
desease management program include self management education by nurse on 6months.
干预措施: usual care (Other)
结局指标
主要结局
Framingham Risk Score: general cardiovascular disease 10 year risk
时间窗: 2.5 years
Use score of Framingham Risk Score: general cardiovascular disease 10 year risk
次要结局
- Evaluated subject frequency of keeping the prescribed diet(2.5 years)
- body weight(2.5 years)
- body mass index(2.5 years)
- blood pressure(2.5 years)
- self-efficacy degree(2.5 years)
- All-cause mortality(2.5 years)
- Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease)(2.5 years)
- cholesterol(2.5 years)
- serum creatinine(2.5 years)
- blood urea nitrogen(2.5 years)
- glycated hemoglobin (HbA1c)(2.5 years)
- blood glucose(2.5 years)
- prothronbin time international rate(2.5 years)
- Mental Depression degree(2.5 years)
- Qiality of Life (QOL) degree(2.5 years)
- Evaluated subject frequency of exercising(2.5 years)
- Evaluated subject frequency of checking blood pressure(2.5 years)
- Evaluated subject frequency of taking medicine(2.5 years)
研究者
Michiko Moriyama
Institute of biomedical and health sciences
Hiroshima University