UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056515 |
|---|---|
| Receipt number | R000064586 |
| Scientific Title | The effect of a program aimed at promoting the autonomy of participants in "gathering places" for elderly care prevention. |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2024/12/20 14:42:13 |
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Basic information
Public title
The effect of a program aimed at promoting the autonomy of participants in "gathering places" for elderly care prevention.
Acronym
The effect of a program aimed at promoting the autonomy of participants in "gathering places" for elderly care prevention.
Scientific Title
The effect of a program aimed at promoting the autonomy of participants in "gathering places" for elderly care prevention.
Scientific Title:Acronym
The effect of a program aimed at promoting the autonomy of participants in "gathering places" for elderly care prevention.
Region
| Japan |
Condition
Condition
elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A program will be designed and implemented within the gathering places for elderly participants, aimed at enhancing their awareness of actively participating by taking on roles. This program aims to improve psychosocial functions related to care prevention and reduce the burden on staff. The effectiveness of the program will be evaluated over time through a questionnaire survey on participants' psychosocial functions, physical function measurements, as well as a questionnaire and interview survey regarding the operational burden on staff.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in participants' psychosocial functions: Psychological health (WHO-5 Well-Being Index).
Key secondary outcomes
1.Changes in participants' psychosocial functions:
Self-efficacy (GSES)
Social health (Lubben Social Network Scale; LSN-6)
Questionnaire on autonomy and role awareness in program participation
2.Operational staff's perceived burden:
Profile of Mood States (POMS)
NASA Task Load Index (NASA-TLX)
Interviews on operational burden (semi-structured interviews)
3.Changes in physical function (to check for abnormal changes due to conditions or diseases):
SPPB (Standing balance test, Rising test, Walking speed test)
Grip strength
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention 1: Raising awareness of autonomy and role awareness:
The researcher will deliver a lecture on care prevention, emphasizing the importance of autonomy and role awareness when participating in the gathering place, based on the results of previous studies. (Participants will understand the effects of autonomy and role awareness on their own health.)
Intervention 2: Selection of a program that encourages active participation:
The researcher will use an interest checklist to survey the interests of all participants, graph the results, and share them with everyone. Based on this, the program content that all participants will engage in together will be discussed and decided. The researcher will support the discussion process, and the participants, with the participation of the operational staff, will conduct the discussion themselves. (Participation in the decision-making process leads to increased autonomy and role awareness.)
Intervention 3: Regular evaluation and confirmation of effects:
The researcher will regularly evaluate psychosocial and physical functions and share the results with the participants. By confirming the effects of activities in the gathering place, participants will be able to reflect on and revise the program content as needed, ensuring that the results motivate them for the next step. (Confirming the effects serves as motivation for future actions.)
Interventions/Control_2
Conventional program (where the organizer determines the content, and participants engage passively).
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly individuals who attend community-led gathering places in Kobe City.
Key exclusion criteria
Participants who attend less than 60% of the program sessions during the intervention period.
Individuals who experience significant changes in health or physical/mental function due to diseases or conditions (e.g., a sudden decline in physical function that is not typically observed in the measurement of physical function).
Data from individuals who meet the exclusion criteria will not be included in the analysis, but they will still be allowed to participate in the program.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsunehiro |
| Middle name | |
| Last name | Otsuka |
Organization
Hyogo Medical University
Division name
Faculty of rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima Cyuouku Kobe Hyogo
TEL
0783043185
ts-ootsuka@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsunehiro |
| Middle name | |
| Last name | Otsuka |
Organization
Hyogo Medical University
Division name
Faculty of rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima Cyuouku Kobe Hyogo
TEL
0783043185
Homepage URL
ts-ootsuka@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Tsunehiro Otsuka
Funding Source
Organization
none
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
Hyogo Medical University ethics committee
Address
1-1 Mukogawacyo Nishinomiya Hyogo
Tel
0798456111
chizai@hyo-med.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
| 2024 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064586
