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

NCT00281034 | Completed DMC

• 2 other identifiers: OASIS-2005oasis-2007
• Study Type: observational
• Target: 2,069
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• score of SF-36

  0, 8 week, 24 week

Study Arms (1)

OASIS Study Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Univercity, Main hospital, general Hospital,0pen

You may qualify if:

• 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

You may not qualify if:

• 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 epilepsy6. Patients whom the investigator judges are not suitable to participate in the study

Sponsors & Collaborators

• Kyorin Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tachikawa, Tokyo, 190-8531, Japan

Location

Related Publications (1)

• 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.

  PMID: 20145390 DERIVED

MeSH Terms

Conditions

Stroke; Brain Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yukito Shinohara, MD

  Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 24, 2006
• Study Start: September 1, 2005
• Study Completion: July 1, 2007
• Last Updated: April 12, 2012

Record last verified: 2012-04

Locations

JP (1)