UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062717 |
|---|---|
| Receipt number | R000071806 |
| Scientific Title | Associations of Prestroke Lifestyle, Health Awareness, and Social Background With Postdischarge Continuity of Care, Long-Term Outcomes, and Quality of Life After Stroke: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/27 22:35:48 |
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Basic information
Public title
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
Acronym
Prestroke Living Circumstances and Long-Term Outcomes Study
Scientific Title
Associations of Prestroke Lifestyle, Health Awareness, and Social Background With Postdischarge Continuity of Care, Long-Term Outcomes, and Quality of Life After Stroke: A Prospective Observational Study
Scientific Title:Acronym
PRE-LIFE Stroke Study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Assessment of the associations of social background factors with adherence to postdischarge care, long-term functional outcomes, and quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient-reported outcomes assessed using the Stroke Impact Scale version 3.0 (SIS 3.0) at 3 and 12 months after stroke onset
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Okumura |
Organization
The Jikei University School of Medicine
Division name
Neurology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
0334331111
kuromaru.mate@gmail.com
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Okumura |
Organization
The Jikei University School of Medicine
Division name
Neurology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
0334331111
Homepage URL
kuromaru.mate@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
0334331111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational cohort study of patients with acute stroke. Patients who meet the eligibility criteria and provide written informed consent during the study period will be enrolled. The associations of prestroke lifestyle, health awareness, and social background with adherence to postdischarge care, functional outcomes, patient-reported outcomes, and quality of life will be evaluated at discharge and at 3 and 12 months after stroke onset.
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071806
