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Ischemic StrokeNCT02121327

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

A study testing disease management in people with Ischemic Stroke, run by Hiroshima University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
disease management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
1 siteJapan
Study dates
Sep 2010to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Hiroshima University

    Hiroshima, Hiroshima, 734-8553

Other trials in Japan

About this study

Official title: Disease Management Program (DMP) Stroke Trial

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.

Conditions
Ischemic Stroke
Being tested
disease management, usual care
Keywords
stroke, disease management programs, self-management
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • disease managementOther

    Also called Intervention of disease management program

    disease management program include self management education

  • usual careOther

    usual care group receive regular outpatient treatment

Study groups in NCT02121327
Study groupRoleWhat they receive
usual careActive comparatorusual care group receive regular outpatient treatment
Receives: Other: usual care
disease managementExperimentaldesease management program include self management education by nurse on 6months.
Receives: Other: disease management; Other: usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Framingham Risk Score: general cardiovascular disease 10 year risk

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

    Measured: 2.5 years

Secondary outcomes (18)

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

    Questionnaire to a patient, and checking it by a nurse

    Measured: 2.5 years

  2. All-cause mortality

    Questionnaire to a patient, and checking it by a nurse

    Measured: 2.5 years

  3. body weight

    Questionnaire to a patient

    Measured: 2.5 years

  4. body mass index

    Calculation of height and the weight of the patient

    Measured: 2.5 years

  5. blood pressure

    Questionnaire to a patient

    Measured: 2.5 years

  6. cholesterol

    total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride The patient mails the copy of the blood test result

    Measured: 2.5 years

  7. serum creatinine

    The patient mails the copy of the blood test result

    Measured: 2.5 years

  8. blood urea nitrogen

    The patient mails the copy of the blood test result

    Measured: 2.5 years

  9. glycated hemoglobin (HbA1c)

    The patient mails the copy of the blood test result

    Measured: 2.5 years

  10. blood glucose

    The patient mails the copy of the blood test result

    Measured: 2.5 years

  11. prothronbin time international rate

    only as for the necessary paticipant The patient mails the copy of the blood test result

    Measured: 2.5 years

  12. Mental Depression degree

    Using score of The Center for Epidemiologic Depression Scale (CES-D)

    Measured: 2.5 years

  13. self-efficacy degree

    Using score of self-efficacy scale on health behavior in patient with chronic disease

    Measured: 2.5 years

  14. Qiality of Life (QOL) degree

    Using score of MOS 36-item short form (SF-36)

    Measured: 2.5 years

  15. Evaluated subject frequency of checking blood pressure

    Questionnaire to a patient

    Measured: 2.5 years

  16. Evaluated subject frequency of taking medicine

    Questionnaire to a patient

    Measured: 2.5 years

  17. Evaluated subject frequency of keeping the prescribed diet

    Questionnaire to a patient

    Measured: 2.5 years

  18. Evaluated subject frequency of exercising

    Questionnaire to a patient

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2014 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121327
Sponsor's protocol ID
21171401
Status last verified
Feb 2018
First submitted
15 Jan 2014
Last updated
22 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34813082

  • 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.

    PubMed 30802185

Questions about this trial

What is this clinical trial studying?

A study testing disease management in people with Ischemic Stroke, run by Hiroshima University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Framingham Risk Score: general cardiovascular disease 10 year risk (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02121327, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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