Overview

This trial is active, not recruiting.

Condition ischemic stroke
Treatments disease management, usual care
Sponsor Hiroshima University
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date September 2010
End date September 2015
Trial size 321 participants
Trial identifier NCT02121327, 21171401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
usual care group receive regular outpatient treatment
usual care usual care
usual care group receive regular outpatient treatment
(Experimental)
desease management program include self management education by nurse on 6months.
disease management Intervention of disease management program
disease management program include self management education
usual care usual care
usual care group receive regular outpatient treatment

Primary Outcomes

Measure
Stroke recurrence and Stroke death
time frame: 2.5 years

Secondary Outcomes

Measure
Framingham risk score: General cardiovascular disease 10-year risk
time frame: 2.5 years
body weight
time frame: 2.5 years
body mass index
time frame: 2.5 years
blood pressure
time frame: 2.5 years
cholesterol
time frame: 2.5 years
serum creatinine
time frame: 2.5 years
blood urea nitrogen
time frame: 2.5 years
glycated hemoglobin (HbA1c)
time frame: 2.5 years
blood glucose
time frame: 2.5 years
prothronbin time international rate
time frame: 2.5 years
The Center for Epidemiologic Depression Scale (CES-D)
time frame: 2.5 years
self-efficacy scale on health behavior in patient with chronic disease
time frame: 2.5 years
MOS 36-item short form (SF-36)
time frame: 2.5 years
Evaluated subject frequency of checking blood pressure
time frame: 2.5 years
Evaluated subject frequency of taking medicine
time frame: 2.5 years
Evaluated subject frequency of keeping the prescribed diet
time frame: 2.5 years
Evaluated subject frequency of exercising
time frame: 2.5 years

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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.

Additional Information

Official title Disease Management Program (DMP) Stroke Trial
Principal investigator Michiko Moriyama, RN, PhD.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Hiroshima University.