OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)

April 10, 2012 updated by: Yukito Shinohara, Kyorin Pharmaceutical Co.,Ltd

Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)

  1. To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan
  2. Chronic brain infarction in Japan is better than EU/USA

Study Overview

Status

Completed

Conditions

Detailed Description

Period:2005-2007

Observation Time:baseline, 8week, 24week

matters investigated:

  1. QOL determination using SF-36 v2
  2. Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)

Study Type

Observational

Enrollment (Actual)

2069

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Tachikawa-City, Tokyo, Japan, 190-8531
        • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Univercity, Main hospital, general Hospital,0pen

Description

Inclusion Criteria:

  1. Patients whose last attack occurred more than 1 month ago
  2. Outpatients (including hospitalization for rehabilitation)
  3. Japanese nationality
  4. Patients who consented to participate in this study
  5. Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction

Exclusion Criteria:

  1. Patients who cannot read, understand and fill in the questionnaire by themselves
  2. Patients who idle their time away
  3. Patients who are hospitalized
  4. Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction
  5. Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy6. Patients whom the investigator judges are not suitable to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OASIS Study Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
score of SF-36
Time Frame: 0, 8 week, 24 week
0, 8 week, 24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin Pharmaceutical Co.,Ltd

Investigators

  • Study Chair: Yukito Shinohara, MD, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

January 23, 2006

First Submitted That Met QC Criteria

January 23, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OASIS-2005
  • oasis-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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