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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Other: disease management; Other: usual care

• Registration Number: NCT02121327
• Lead Sponsor: Hiroshima University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2017-02
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
disease management	usual care	desease management program include self management education by nurse on 6months.
disease management	disease management	desease management program include self management education by nurse on 6months.
usual care	usual care	usual care group receive regular outpatient treatment

Primary Outcome Measures

Name	Time	Method
Framingham Risk Score: general cardiovascular disease 10 year risk	2.5 years	Use score of Framingham Risk Score: general cardiovascular disease 10 year risk

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima city, Hiroshima, Japan