UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052410 |
|---|---|
| Receipt number | R000059713 |
| Scientific Title | Development of an individualized program aimed at maintaining the health of elderly people living alone, ranging from healthy to support level 2 - Focusing on frailty and sarcopenia - |
| Date of disclosure of the study information | 2023/10/06 |
| Last modified on | 2024/04/04 09:11:30 |
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Basic information
Public title
Development of an individualized program aimed at maintaining the health of elderly people living alone, ranging from healthy to support level 2 - Focusing on frailty and sarcopenia -
Acronym
Development of an individualized program aimed at maintaining the health of elderly people living alone, ranging from healthy to support level 2 - Focusing on frailty and sarcopenia -
Scientific Title
Development of an individualized program aimed at maintaining the health of elderly people living alone, ranging from healthy to support level 2 - Focusing on frailty and sarcopenia -
Scientific Title:Acronym
Development of an individualized program aimed at maintaining the health of elderly people living alone, ranging from healthy to support level 2 - Focusing on frailty and sarcopenia -
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Build an individualized community program aimed at preventing frailty and sarcopenia for elderly people living alone in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass, grip strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Frailty prevention
Interventions/Control_2
control group
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
Elderly people living alone
Key exclusion criteria
Other than elderly people living alone
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Yamada |
Organization
Gifu University of Medical Science
Division name
Faculty of Nursing
Zip code
5090293
Address
4-3-3 Nijigaoka, Kani City, Gifu Prefecture
TEL
0574-65-6555
yyamada@u-gifu-ms.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Yamada |
Organization
Gifu University Of Medical Science
Division name
Faculty of Nursing
Zip code
5090293
Address
4-3-3 Nijigaoka, Kani City, Gifu Prefecture
TEL
0574-65-6555
Homepage URL
yyamada@u-gifu-ms.ac.jp
Sponsor or person
Institute
Gifu University Of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Gifu University Of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Of Medical Science
Address
4-3-3 Nijigaoka, Kani City, Gifu Prefecture
Tel
0574-65-6555
yyamada@u-gifu-ms.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
| 2023 | Year | 10 | Month | 06 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
