UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036617 |
|---|---|
| Receipt number | R000041718 |
| Scientific Title | Community-based Intervention Study |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2021/04/29 15:34:16 |
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Basic information
Public title
Research on Multi-generational Drama Workshops to Promote Well-being of the Elderly
Acronym
Research on Multi-generational Drama Workshops
Scientific Title
Community-based Intervention Study
Scientific Title:Acronym
Intervention Study
Region
| Japan |
Condition
Condition
Frail Elderly
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the change of well-being(Ikigai) of the elderly who participated in multi-generational drama workshops.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ikigai Scale for the Elderly (Ikigai-9)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participation in the multi-generational drama workshops
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
Those who are able to give consent by themselves or their representatives, not limited by the diseases or disabilities they have, including cognitive impairment.
Key exclusion criteria
Those who are not able to participate in recreation programs at day-care services.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Family and Community Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2416
machiko@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Machiko |
| Middle name | |
| Last name | Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Family and Community Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2416
Homepage URL
fammed@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Life Insurance Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
Tel
053-435-2680
rinri@hama-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
| 2019 | Year | 05 | Month | 07 | 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
27
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | 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
| 2019 | Year | 04 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041718
