UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between Health-Related Quality of Life and Performance/Satisfaction of Social Participation among Elderly Persons in Need of Care
Acronym	Relationship between Health-Related Quality of Life and Performance/Satisfaction of Social Participation among Elderly Persons in Need of Care
Scientific Title	Relationship between Health-Related Quality of Life and Performance/Satisfaction of Social Participation among Elderly Persons in Need of Care
Scientific Title:Acronym	Relationship between Health-Related Quality of Life and Performance/Satisfaction of Social Participation among Elderly Persons in Need of Care
Region	Japan

Condition
Condition	Elderly people who require nursing care and who use home-visit or day-care rehabilitation services under long-term care insurance
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the differences in the relationship between objective performance of social participation and subjective satisfaction with health-related quality of life in elderly people requiring nursing care.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Basic Information Physical Factors Psychological factors Social factors Social Participation Health-related QOL
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly people who require nursing care and who use home-visit or day-care rehabilitation services under long-term care insurance
Key exclusion criteria	Elderly people with dementia who are ranked less than I in the level of independence in daily life Those with visual or hearing impairments that make it difficult to complete the questionnaire Residents of facilities such as serviced apartments for the elderly, who are unable to give consent for the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Iki
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Division name	rehabilitation department
Zip code	5730086
Address	9-25-202, Kourien-cho, Hirakata-shi, Osaka
TEL	0728351010
Email	kawaguchi.ns.reha@gmail.com

Public contact
Name of contact person	1st name Shinya Middle name Last name Iki
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Division name	rehabilitation department
Zip code	5730086
Address	9-25-202, Kourien-cho, Hirakata-shi, Osaka
TEL	0728351010
Homepage URL
Email	kawaguchi.ns.reha@gmail.com

Sponsor
Institute	Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

Funding Source
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nishiyamato Rehabilitation Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Address	9-25-202, Kourien-cho, Hirakata-shi, Osaka
Tel	0728351010
Email	kawaguchi.ns.reha@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	29
Org. issuing International ID_1	Nishiyamato Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 16 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 16 Day
Date of IRB	2021 Year 10 Month 15 Day
Anticipated trial start date	2021 Year 10 Month 16 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 10 Month 16 Day
Last modified on	2021 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052260