Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062717) titled 'A Prospective Observational Study of How Lifestyle, Health Awareness, and Social Circumstances Before Stroke Relate to Continued Care, Long-Term Health, and Quality of Life After Discharge' on Aug. 31.
Study Type:
Observational
Primary Sponsor:
Institute - The Jikei University School of Medicine
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to investigate the long-term associations of social background factors-including lifestyle, family and living arrangements, employment status, and social support-with functional outcomes and quality of life among patients with stroke. Assessments covering the prestroke period, discharge, and postdischarge follow-up will be conducted using multiple measures, including a questionnaire developed at our institution and the Stroke Impact Scale version 3.0.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants must meet all of the following criteria and provide written informed consent:
1. Patients aged 20 years or older who are admitted to the Department of Neurology at our hospital with acute stroke, including ischemic stroke, transient ischemic attack, or intracerebral hemorrhage.
2. Patients who are able to respond to the questionnaire independently or, when necessary, with assistance from family members or caregivers.
3. Patients with a prestroke modified Rankin Scale score of 0-2.
4. Patients who, after receiving a sufficient explanation of the study and fully understanding its contents, voluntarily provide written informed consent to participate.
Key exclusion criteria - 1. Patients judged unable to accurately understand the purpose of and respond to the questionnaire because of severe cognitive impairment, impaired consciousness, psychiatric illness, or other conditions, defined as a Revised Hasegawa's Dementia Scale score of <=10, a Mini-Mental State Examination score of <=10, or an equivalent clinical condition.
2. Patients with severe aphasia, visual impairment, or other conditions that make it extremely difficult for them to communicate their responses, even with assistance such as having the questions read aloud or their responses transcribed by another person.
3. Patients deemed ineligible for participation by the principal investigator or other study investigators.
Target Size - 600
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 01 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071806
Disclaimer: Curated by HT Syndication.