Disease Management Program (DMP) Stroke Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hiroshima University
- Enrollment
- 321
- Locations
- 2
- Primary Endpoint
- Framingham Risk Score: general cardiovascular disease 10 year risk
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
usual care
usual care group receive regular outpatient treatment
Intervention: usual care (Other)
disease management
desease management program include self management education by nurse on 6months.
Intervention: disease management (Other)
disease management
desease management program include self management education by nurse on 6months.
Intervention: usual care (Other)
Outcomes
Primary Outcomes
Framingham Risk Score: general cardiovascular disease 10 year risk
Time Frame: 2.5 years
Use score of Framingham Risk Score: general cardiovascular disease 10 year risk
Secondary Outcomes
- All-cause mortality(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)
- 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)
- Evaluated subject frequency of keeping the prescribed diet(2.5 years)
Investigators
Michiko Moriyama
Institute of biomedical and health sciences
Hiroshima University