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Completed

NCT Number: NCT02121327

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8553, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Disease management

Other

disease management program include self management education

Other names: Intervention of disease management program

Usual Care

Other

usual care group receive regular outpatient treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

Disease Management Program (DMP) Stroke Trial

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Apr 23, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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