NCT00281034CompletedNot Applicable
Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)
Kyorin Pharmaceutical Co.,Ltd1 site in 1 country2,069 target enrollmentStarted: September 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,069
- Locations
- 1
- Primary Endpoint
- score of SF-36
Study Overview
Brief Summary
- To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan
- Chronic brain infarction in Japan is better than EU/USA
Detailed Description
Period:2005-2007
Observation Time:baseline, 8week, 24week
matters investigated:
- QOL determination using SF-36 v2
- 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients whose last attack occurred more than 1 month ago
- •Outpatients (including hospitalization for rehabilitation)
- •Japanese nationality
- •Patients who consented to participate in this study
- •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
- •Patients who cannot read, understand and fill in the questionnaire by themselves
- •Patients who idle their time away
- •Patients who are hospitalized
- •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
- •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 epilepsy
- •Patients whom the investigator judges are not suitable to participate in the study
Outcomes
Primary Outcomes
score of SF-36
Time Frame: 0, 8 week, 24 week
Secondary Outcomes
No secondary outcomes reported
Investigators
Yukito Shinohara
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Kyorin Pharmaceutical Co.,Ltd
Study Sites (1)
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