UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058866 |
|---|---|
| Receipt number | R000067226 |
| Scientific Title | The effects of an assistive device utilization program aimed at improving activities of daily living in hospitalized older adults on both patients and healthcare professionals |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/22 12:46:49 |
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Basic information
Public title
The effects of an assistive device utilization program aimed at improving activities of daily living in hospitalized older adults on both patients and healthcare professionals
Acronym
The effects of an assistive device utilization program
Scientific Title
The effects of an assistive device utilization program aimed at improving activities of daily living in hospitalized older adults on both patients and healthcare professionals
Scientific Title:Acronym
The effects of an assistive device utilization program
Region
| Japan |
Condition
Condition
Older adults (hospitalized)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the impact of an assistive device utilization program on hospitalized older adults and healthcare professionals by using both quantitative and qualitative data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measures
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention involves implementing the assistive device utilization program, while data from a historical control group will be used for comparison.
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
The intervention group will consist of inpatients admitted to the community-based integrated care ward of the study facility, while the control group will be selected from patients admitted to the same ward prior to the intervention. Both the intervention and historical control groups will include patients aged 65 years or older who were admitted to the community-based integrated care ward and prescribed rehabilitation.
Key exclusion criteria
The exclusion criterion will be patients for whom assessment data (e.g., FIM) could not be obtained at either admission or discharge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kondo |
Organization
Gunma Paz University
Division name
Department of Rehabilitation
Zip code
3700006
Address
1-7-1 Tonya, Takasaki ,Gunma
TEL
0273653366
kenkondoot@gmail.com
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kondo |
Organization
Gunma Paz University
Division name
Department of Rehabilitation
Zip code
3700006
Address
1-7-1 Tonya, Takasaki ,Gunma
TEL
0273653366
Homepage URL
kenkondoot@gmail.com
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
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
Gunma Paz University Research Ethics Committee
Address
1-7-1 Tonyamachi, Takasaki, Gunma
Tel
0273653366
kenkondoot@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
群馬県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 01 | 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
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067226
