UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057402 |
|---|---|
| Receipt number | R000065587 |
| Scientific Title | Development of the Japanese version of the Impact on Participation and Autonomy-Older persons: Reliability and validity for older people requiring long-term care |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/03/26 10:48:16 |
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Basic information
Public title
Development of the Japanese version of the Impact on Participation and Autonomy-Older persons: Reliability and validity for older people requiring long-term care
Acronym
Development of the Japanese version of the Impact on Participation and Autonomy-Older persons
Scientific Title
Development of the Japanese version of the Impact on Participation and Autonomy-Older persons: Reliability and validity for older people requiring long-term care
Scientific Title:Acronym
Development of the Japanese version of the Impact on Participation and Autonomy-Older persons
Region
| Japan |
Condition
Condition
older people requiring long-term care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a Japanese version of the Impact on Participation and Autonomy-Older persons.
Basic objectives2
Others
Basic objectives -Others
To test the reliability and validity of the Japanese version of the Impact on Participation and Autonomy-Older persons for older people requiring long-term care.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Impact on Participation and Autonomy-Older persons
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
older people aged 65 and over who require long-term care
Key exclusion criteria
The exclusion criteria were:
(1) cognitive impairment
(2) facility residents
(3) history of psychological disorders
(4) less than 90 day since leaving hospital
(5) general condition is unstable
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ogawa |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
t.ogawa.pt@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ogawa |
Organization
Nishiyamato Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
639-0218
Address
3-2-2 Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-71-6688
Homepage URL
t.ogawa.pt@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Uehiro Foundation on Ethics and Education
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Metropolitan University, Saitama Medical University, National Center for Geriatrics and Gerontology, Ibaraki Prefectural University of Health Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
0745-71-6688
kansa@kio.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
イムス札幌内科リハビリテーション病院（北海道），介護老人保健施設ケアセンター虹（大阪府），華陽診療所デイサービスきねん（岐阜県），株式会社Luxem（神奈川県），川口脳神経外科リハビリクリニック（大阪府），関西医科大学くずは病院（大阪府），白浜はまゆう病院（和歌山県），摂南総合病院（大阪府），長崎記念病院（長崎県），西大和リハビリテーション病院（奈良県），八千代リハビリデイサービス彩（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 26 | 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
| 2025 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study design
Cross-sectional study (multicenter study)
2. Questionnaire items
Subject characteristics
Functional Ambulation Classification of the Hospital at Sagunto (Viosca E, et al. 2005)
Barthel Index(Mahoney FI, et al. 1965)
Revised Frenchay Activities Index (Suenaga, et al. 2000)
Social Support (Murata C, et al. 2017)
SF-8 (Tokuda Y, et al. 2009)
3. Analysis
Validity is examined using factor analysis to assess factor structure. In addition, criterion-related validity is assessed by comparison with other questionnaires. Reliability is assessed using Cronbach's alpha, intraclass correlation coefficient and kappa coefficient. A test-retest method will be used with some participants. We will add the other analysis according to the needs.
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065587
