Clinical trial NCT00281034: OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)
Official title: Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: brain infarction
SF-36
HRQOL
Japan
Post-stroke syndrome
Lead sponsor: Kyorin Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2006-01-24
Enrollment: 2069
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Univercity, Main hospital, general Hospital,0pen

Brief summary: 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: score of SF-36
timeFrame: 0, 8 week, 24 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tachikawa-City
country: Japan
facility: Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
state: Tokyo
Study officials:
affiliation: Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
name: Yukito Shinohara, MD
role: STUDY_CHAIR
References:
citation: Shinohara Y; OASIS Study Group. Factors affecting health-related quality of life assessed with the SF-36v2 health survey in outpatients with chronic-stage ischemic stroke in Japan--cross-sectional analysis of the OASIS study. Cerebrovasc Dis. 2010;29(4):361-71. doi: 10.1159/000281834. Epub 2010 Feb 9.