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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00281034

Enrollment

2069

Registered

2006-01-24

Start date

2005-09-30

Completion date

2007-07-31

Last updated

2012-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

brain infarction, SF-36, HRQOL, Japan, Post-stroke syndrome

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
score of SF-36	0, 8 week, 24 week

Countries

Japan

Outcome results