UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026448
Receipt number R000030385
Scientific Title Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen
Date of disclosure of the study information 2017/03/07
Last modified on 2017/03/07 19:13:47

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Basic information

Public title

Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen

Acronym

Effectiveness of the occupational therapy program using sspc.

Scientific Title

Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen

Scientific Title:Acronym

Effectiveness of the occupational therapy program using sspc.

Region

Japan


Condition

Condition

Geriatrics
Psychiatry

Classification by specialty

Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to understand HRQOL and daily life outcome for older adults who take a standard occupational therapy using crafts and those who take an occupational therapy using cosmetic which we have been developing.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

WHOQOL-BREF
SF-12
EQ-5D-5L
OSA ver.2.1
Frenchay Activities Index

Key secondary outcomes

MMSE
Budget


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Eight times a four month period.Program pertains to instruction/practice of daily life and cosmetic skills in a group.In seventh times, participants would do one occupation he/she wants to do(i.e, shopping, outdoor, studying).

Interventions/Control_2

Eight times a four month period.We perform the group program using crafts as a standard program of the occupational therapy.

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

65 years-old <

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Subjects entitled to long term care insurance community support program and/or preventive support project.

Key exclusion criteria

Excluded are persons who receive care grade1 and over.

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitomi Ishibashi

Organization

Tokyo University of Technology

Division name

Dep. of Occu.Ther., School of Health Sciences

Zip code


Address

5-23-22 Nishi-kamata, Ota-city, Tokyo, Japan

TEL

81-3-6424-2145

Email

hishibashiteu@stf.teu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitomi Ishibashi

Organization

Tokyo University of Technology

Division name

Dep. of Occu.Ther., School of Health Sciences

Zip code


Address

5-23-22 Nishi-kamata, Ota-city, Tokyo, Japan

TEL

81-3-6424-2145

Homepage URL


Email

hishibashiteu@stf.teu.ac.jp


Sponsor or person

Institute

Tokyo University of Technology, School of Health Sciences, department of occupational therapy

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Tokyo Metropolitan University, Kao Corporation

Name of secondary funder(s)

Japan society for the promotion of science, Grant-in-Aid for Young Scientists (B)


IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 03 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

Date of protocol fixation

2016 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 06 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 08 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 07 Day

Last modified on

2017 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030385


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name