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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036617
Receipt No. R000041718
Scientific Title Community-based Intervention Study
Date of disclosure of the study information 2019/05/07
Last modified on 2019/04/27

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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
Email 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
Email fammed@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 09 Day
Date of IRB
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
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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