UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056179 |
|---|---|
| Receipt number | R000064195 |
| Scientific Title | Feasibility of outing support service respecting the free will of older adults and people requiring care and its effect on their physical and mental functions |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2025/11/21 06:00:45 |
* 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
Verification of feasibility and effectiveness of outing support services for older adults and people requiring care
Acronym
Feasibility and effects of outing support service
Scientific Title
Feasibility of outing support service respecting the free will of older adults and people requiring care and its effect on their physical and mental functions
Scientific Title:Acronym
Feasibility of outing support service respecting the free will of older adults and people requiring care and its effect on their physical and mental functions
Region
| Japan |
Condition
Condition
older adults and people requiring care
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the feasibility of an intervention program that integrates the selection of places to go out and the provision of information about the surrounding area according to the needs of the elderly and people requiring care. We will also evaluate the reactions of the people around them in order to identify social issues related to outings for the elderly and those who require nursing care.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of outing activities
Key secondary outcomes
Vitality Index, Geriatric Depression Scale-15, Distance and speed traveled during outings, sleeping conditions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Integrate information to support outings with the desired destination as the destination. Specifically, (i) the means of transportation to the destination and necessary mobility arrangements are identified, (ii) information on barrier-free access and physical considerations such as places to eat, drink, and rest is collected at the destination, and (iii) a time schedule for the trip and stay at the destination is prepared in advance and provided to the subject in advance. Based on this information, the participants are asked to go out with the assistance of staff at the nursing care facility where the program is held.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fifty users of the facilities (residents, users of short-term and day-care services, etc.) and their family members, and fifty nursing home staff members of the facilities will be included in the study.
The selection criteria for the facility users and their family members are as follows: (1) they must be able to use a walking aid or wheelchair to move around outside their rooms, and (2) they and their family members must be able to understand the content of the study and agree to participate in it.
The selection criteria for staff members are that they must have daily contact with the subject facility users.
Key exclusion criteria
(1)Cases in which the patient has difficulty understanding and following instructions due to cognitive decline or language impairment, and in which there is a risk that safety cannot be ensured during transportation, and (2) cases in which there is any risk of medical instability such as acute onset of illness or deterioration of general conditions, are excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Otaka |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
474-8511
Address
7-430 Morioka, Obu, Aichi JAPAN
TEL
0562-46-2311
eotaka@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Otaka |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
474-8511
Address
7-430 Morioka, Obu, Aichi JAPAN
TEL
0562-46-2311
Homepage URL
eotaka@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
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
National Center for Geriatrics and Gerontology
Address
7-430 Morioka, Obu, Aichi JAPAN
Tel
0562-46-2311
yaday@ncgg.go.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
| 2024 | Year | 11 | Month | 18 | 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
7
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
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064195
