The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Disease Management Program (DMP) Stroke Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: disease management
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care<br>usual care group receive regular outpatient treatment | Other: usual care<br>* usual care group receive regular outpatient treatment<br>|
| Experimental: disease management<br>desease management program include self management education by nurse on 6months. | Other: disease management<br>* disease management program include self management education<br>* Other names: Intervention of disease management program;Other: usual care<br>* usual care group receive regular outpatient treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham Risk Score: general cardiovascular disease 10 year risk | Use score of Framingham Risk Score: general cardiovascular disease 10 year risk | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease) | Questionnaire to a patient, and checking it by a nurse | 2.5 years | 
| All-cause mortality | Questionnaire to a patient, and checking it by a nurse | 2.5 years | 
| body weight | Questionnaire to a patient | 2.5 years | 
| body mass index | Calculation of height and the weight of the patient | 2.5 years | 
| blood pressure | Questionnaire to a patient | 2.5 years | 
| cholesterol | total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride The patient mails the copy of the blood test result | 2.5 years | 
| serum creatinine | The patient mails the copy of the blood test result | 2.5 years | 
| blood urea nitrogen | The patient mails the copy of the blood test result | 2.5 years | 
| glycated hemoglobin (HbA1c) | The patient mails the copy of the blood test result | 2.5 years | 
| blood glucose | The patient mails the copy of the blood test result | 2.5 years | 
| prothronbin time international rate | only as for the necessary paticipant The patient mails the copy of the blood test result | 2.5 years | 
| Mental Depression degree | Using score of The Center for Epidemiologic Depression Scale (CES-D) | 2.5 years | 
| self-efficacy degree | Using score of self-efficacy scale on health behavior in patient with chronic disease | 2.5 years | 
| Qiality of Life (QOL) degree | Using score of MOS 36-item short form (SF-36) | 2.5 years | 
| Evaluated subject frequency of checking blood pressure | Questionnaire to a patient | 2.5 years | 
| Evaluated subject frequency of taking medicine | Questionnaire to a patient | 2.5 years | 
| Evaluated subject frequency of keeping the prescribed diet | Questionnaire to a patient | 2.5 years | 
| Evaluated subject frequency of exercising | Questionnaire to a patient | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, disease management programs, self-management