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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
disease management
usual care
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ischemic Stroke focused on measuring stroke, disease management programs, self-management

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hiroshima University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual care

disease management

Arm Description

usual care group receive regular outpatient treatment

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2014
Last Updated
February 21, 2018
Sponsor
Hiroshima University
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT02121327
Brief Title
The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke
Official Title
Disease Management Program (DMP) Stroke Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
stroke, disease management programs, self-management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
Active Comparator
Arm Description
usual care group receive regular outpatient treatment
Arm Title
disease management
Arm Type
Experimental
Arm Description
desease management program include self management education by nurse on 6months.
Intervention Type
Other
Intervention Name(s)
disease management
Other Intervention Name(s)
Intervention of disease management program
Intervention Description
disease management program include self management education
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
usual care group receive regular outpatient treatment
Primary Outcome Measure Information:
Title
Framingham Risk Score: general cardiovascular disease 10 year risk
Description
Use score of Framingham Risk Score: general cardiovascular disease 10 year risk
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease)
Description
Questionnaire to a patient, and checking it by a nurse
Time Frame
2.5 years
Title
All-cause mortality
Description
Questionnaire to a patient, and checking it by a nurse
Time Frame
2.5 years
Title
body weight
Description
Questionnaire to a patient
Time Frame
2.5 years
Title
body mass index
Description
Calculation of height and the weight of the patient
Time Frame
2.5 years
Title
blood pressure
Description
Questionnaire to a patient
Time Frame
2.5 years
Title
cholesterol
Description
total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride The patient mails the copy of the blood test result
Time Frame
2.5 years
Title
serum creatinine
Description
The patient mails the copy of the blood test result
Time Frame
2.5 years
Title
blood urea nitrogen
Description
The patient mails the copy of the blood test result
Time Frame
2.5 years
Title
glycated hemoglobin (HbA1c)
Description
The patient mails the copy of the blood test result
Time Frame
2.5 years
Title
blood glucose
Description
The patient mails the copy of the blood test result
Time Frame
2.5 years
Title
prothronbin time international rate
Description
only as for the necessary paticipant The patient mails the copy of the blood test result
Time Frame
2.5 years
Title
Mental Depression degree
Description
Using score of The Center for Epidemiologic Depression Scale (CES-D)
Time Frame
2.5 years
Title
self-efficacy degree
Description
Using score of self-efficacy scale on health behavior in patient with chronic disease
Time Frame
2.5 years
Title
Qiality of Life (QOL) degree
Description
Using score of MOS 36-item short form (SF-36)
Time Frame
2.5 years
Title
Evaluated subject frequency of checking blood pressure
Description
Questionnaire to a patient
Time Frame
2.5 years
Title
Evaluated subject frequency of taking medicine
Description
Questionnaire to a patient
Time Frame
2.5 years
Title
Evaluated subject frequency of keeping the prescribed diet
Description
Questionnaire to a patient
Time Frame
2.5 years
Title
Evaluated subject frequency of exercising
Description
Questionnaire to a patient
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiko Moriyama, RN, PhD.
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima city
State/Province
Hiroshima
ZIP/Postal Code
734-8553
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34813082
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.
Results Reference
derived
PubMed Identifier
30802185
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.
Results Reference
derived

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

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