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

Hiroshima University

Status: Completed

Conditions: Ischemic Stroke

Treatments: Other: usual care; Other: disease management

Study type: Interventional

Funder types: Other

Identifiers

NCT02121327

21171401

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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321 participants in 2 patient groups

usual care

Active Comparator group

Description:

usual care group receive regular outpatient treatment

Treatment:

Other: usual care

disease management

Experimental group

Description:

desease management program include self management education by nurse on 6months.

Treatment:

Other: disease management

Other: usual care