Clinical trial NCT02121327: The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke
Official title: Disease Management Program (DMP) Stroke Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: stroke, disease management programs, self-management
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2014-04-23
Enrollment: 321
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Framingham Risk Score: general cardiovascular disease 10 year risk
timeFrame: 2.5 years
Secondary outcomes:
measure: Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease)
timeFrame: 2.5 years
measure: All-cause mortality
timeFrame: 2.5 years
measure: body weight
timeFrame: 2.5 years
measure: body mass index
timeFrame: 2.5 years
measure: blood pressure
timeFrame: 2.5 years
measure: cholesterol
timeFrame: 2.5 years
measure: serum creatinine
timeFrame: 2.5 years
measure: blood urea nitrogen
timeFrame: 2.5 years
measure: glycated hemoglobin (HbA1c)
timeFrame: 2.5 years
measure: blood glucose
timeFrame: 2.5 years
measure: prothronbin time international rate
timeFrame: 2.5 years
measure: Mental Depression degree
timeFrame: 2.5 years
measure: self-efficacy degree
timeFrame: 2.5 years
measure: Qiality of Life (QOL) degree
timeFrame: 2.5 years
measure: Evaluated subject frequency of checking blood pressure
timeFrame: 2.5 years
measure: Evaluated subject frequency of taking medicine
timeFrame: 2.5 years
measure: Evaluated subject frequency of keeping the prescribed diet
timeFrame: 2.5 years
measure: Evaluated subject frequency of exercising
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Hiroshima city
country: Japan
facility: Hiroshima University
state: Hiroshima
Study officials:
affiliation: Hiroshima University
name: Michiko Moriyama, RN, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Fukuoka Y, Hosomi N, Hyakuta T, Omori T, Ito Y, Uemura J, Yagita Y, Kimura K, Matsumoto M, Moriyama M; for DMP Stroke Trial Investigators. Effects of a Disease Management Program for Preventing Recurrent Ischemic Stroke. Stroke. 2019 Mar;50(3):705-712. doi: 10.1161/STROKEAHA.118.020888.