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

NCT ID: NCT02121327

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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usual care

usual care group receive regular outpatient treatment

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

usual care group receive regular outpatient treatment

disease management

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

Group Type EXPERIMENTAL

disease management

Intervention Type OTHER

disease management program include self management education

usual care

Intervention Type OTHER

usual care group receive regular outpatient treatment

Interventions

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disease management

disease management program include self management education

Intervention Type OTHER

usual care

usual care group receive regular outpatient treatment

Intervention Type OTHER

Other Intervention Names

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Intervention of disease management program

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role collaborator

Hiroshima University

OTHER

Sponsor Role lead

Responsible Party

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Michiko Moriyama

Institute of biomedical and health sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michiko Moriyama, RN, PhD.

Role: PRINCIPAL_INVESTIGATOR

Hiroshima University

Locations

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Hiroshima University

Hiroshima, Hiroshima, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 34813082 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30802185 (View on PubMed)

Other Identifiers

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21171401

Identifier Type: -

Identifier Source: org_study_id

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