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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name