NCT02121327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

6.4 years

First QC Date

January 15, 2014

Last Update Submit

February 21, 2018

Conditions

Ischemic Stroke

Keywords

stroke, disease management programs, self-management

Outcome Measures

Primary Outcomes (1)

  • Framingham Risk Score: general cardiovascular disease 10 year risk

    Use score of Framingham Risk Score: general cardiovascular disease 10 year risk

    2.5 years

Secondary Outcomes (18)

  • Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease)

    2.5 years

  • All-cause mortality

    2.5 years

  • body weight

    2.5 years

  • body mass index

    2.5 years

  • blood pressure

    2.5 years

  • +13 more secondary outcomes

Study Arms (2)

usual care

ACTIVE COMPARATOR

usual care group receive regular outpatient treatment

Other: usual care

disease management

EXPERIMENTAL

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

Other: disease managementOther: usual care

Interventions

disease managementOTHER

disease management program include self management education

Also known as: Intervention of disease management program
disease management
usual careOTHER

usual care group receive regular outpatient treatment

disease managementusual care

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Hiroshima, 734-8553, Japan

Location

Related Publications (2)

  • 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.

    PMID: 34813082DERIVED

  • 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.

    PMID: 30802185DERIVED

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Michiko Moriyama, RN, PhD.

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of biomedical and health sciences

Study Record Dates

First Submitted

January 15, 2014

First Posted

April 23, 2014

Study Start

September 1, 2010

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

JP(1)