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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02121327
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Michiko Moriyama, Hiroshima University

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Other: disease management Other: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Disease Management Program (DMP) Stroke Trial
Actual Study Start Date : September 2010
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: usual care
usual care group receive regular outpatient treatment
Other: usual care
usual care group receive regular outpatient treatment

Experimental: disease management
desease management program include self management education by nurse on 6months.
Other: disease management
disease management program include self management education
Other Name: Intervention of disease management program

Other: usual care
usual care group receive regular outpatient treatment




Primary Outcome Measures :
  1. Framingham Risk Score: general cardiovascular disease 10 year risk [ Time Frame: 2.5 years ]
    Use score of Framingham Risk Score: general cardiovascular disease 10 year risk


Secondary Outcome Measures :
  1. Cumulative incidence rate of stroke recurrence and the complication (cardiovascular disease) [ Time Frame: 2.5 years ]
    Questionnaire to a patient, and checking it by a nurse

  2. All-cause mortality [ Time Frame: 2.5 years ]
    Questionnaire to a patient, and checking it by a nurse

  3. body weight [ Time Frame: 2.5 years ]
    Questionnaire to a patient

  4. body mass index [ Time Frame: 2.5 years ]
    Calculation of height and the weight of the patient

  5. blood pressure [ Time Frame: 2.5 years ]
    Questionnaire to a patient

  6. cholesterol [ Time Frame: 2.5 years ]
    total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride The patient mails the copy of the blood test result

  7. serum creatinine [ Time Frame: 2.5 years ]
    The patient mails the copy of the blood test result

  8. blood urea nitrogen [ Time Frame: 2.5 years ]
    The patient mails the copy of the blood test result

  9. glycated hemoglobin (HbA1c) [ Time Frame: 2.5 years ]
    The patient mails the copy of the blood test result

  10. blood glucose [ Time Frame: 2.5 years ]
    The patient mails the copy of the blood test result

  11. prothronbin time international rate [ Time Frame: 2.5 years ]
    only as for the necessary paticipant The patient mails the copy of the blood test result

  12. Mental Depression degree [ Time Frame: 2.5 years ]
    Using score of The Center for Epidemiologic Depression Scale (CES-D)

  13. self-efficacy degree [ Time Frame: 2.5 years ]
    Using score of self-efficacy scale on health behavior in patient with chronic disease

  14. Qiality of Life (QOL) degree [ Time Frame: 2.5 years ]
    Using score of MOS 36-item short form (SF-36)

  15. Evaluated subject frequency of checking blood pressure [ Time Frame: 2.5 years ]
    Questionnaire to a patient

  16. Evaluated subject frequency of taking medicine [ Time Frame: 2.5 years ]
    Questionnaire to a patient

  17. Evaluated subject frequency of keeping the prescribed diet [ Time Frame: 2.5 years ]
    Questionnaire to a patient

  18. Evaluated subject frequency of exercising [ Time Frame: 2.5 years ]
    Questionnaire to a patient



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121327


Locations
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Japan
Hiroshima University
Hiroshima city, Hiroshima, Japan, 734-8553
Sponsors and Collaborators
Hiroshima University
Ministry of Health, Labour and Welfare, Japan
Investigators
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Principal Investigator: Michiko Moriyama, RN, PhD. Hiroshima University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michiko Moriyama, Institute of biomedical and health sciences, Hiroshima University
ClinicalTrials.gov Identifier: NCT02121327    
Other Study ID Numbers: 21171401
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michiko Moriyama, Hiroshima University:
stroke, disease management programs, self-management
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes