UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058533 |
|---|---|
| Receipt number | R000066930 |
| Scientific Title | Factors associated with frailty and social relationships among elderly residents undergoing hemodialysis treatment in the community: A cross-sectional study |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/21 13:25:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Factors associated with frailty and social relationships among elderly residents undergoing hemodialysis treatment in the community: A cross-sectional study
Acronym
Factors associated with frailty and social relationships among elderly residents undergoing hemodialysis treatment in the community: A cross-sectional study
Scientific Title
Factors associated with frailty and social relationships among elderly residents undergoing hemodialysis treatment in the community: A cross-sectional study
Scientific Title:Acronym
Factors associated with frailty and social relationships among elderly residents undergoing hemodialysis treatment in the community: A cross-sectional study
Region
| Japan |
Condition
Condition
end-stage renal disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the physical frailty and social relationships of elderly people receiving hemodialysis who live in the community
To identify factors related to frailty and social relationships among elderly people receiving hemodialysis who live in the community
Basic objectives2
Others
Basic objectives -Others
To investigate useful measures for the early detection of physical frailty in elderly patients undergoing hemodialysis who reside in the community.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors related to frailty and social relationships among elderly residents undergoing hemodialysis in the community
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
1. Age 65 or older
2. Able to walk independently (use of walking aids permitted)
3. Three months have passed since the initiation of hemodialysis
4. No vascular access on the dominant side
5. Currently receiving hemodialysis at an outpatient clinic
6. Not diagnosed with dementia
7. Able to understand and follow instructions without difficulty
8. Able to complete a questionnaire independently
9. Informed consent obtained via a consent form
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Yoshida |
Organization
Tenshi College
Division name
Graduate School of Nursing and Nutrition
Zip code
065-0013
Address
3-1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo
TEL
011-741-1051
2024h106@student.tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yoshida |
Organization
Tenshi College
Division name
Graduate School of Nursing and Nutrition
Zip code
065-0013
Address
3-1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo
TEL
011-741-1051
Homepage URL
2024h106@student.tenshi.ac.jp
Sponsor or person
Institute
Tenshi College
Institute
Department
Personal name
Funding Source
Organization
Tenshi College
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
Tenshi College
Address
3-1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo
Tel
011-741-1051
soumu@tenshi.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
| 2025 | Year | 07 | Month | 22 | 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 | 06 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Research design
Observational study
2.Survey items
Frailty
Personal attributes
Sleep,swallowing,conversation,etc.
Management information
Registered date
| 2025 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066930
