UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036792
Receipt number R000041832
Scientific Title Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan
Date of disclosure of the study information 2019/05/19
Last modified on 2023/05/29 12:09:20

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Basic information

Public title

Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan

Acronym

Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan

Scientific Title

Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan

Scientific Title:Acronym

Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan

Region

Japan


Condition

Condition

healthy individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the level of the subjective well-being and the predictive factors associated with subjective well-being among the caregivers of the people living with dementia in Japan

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Satisfaction With Life Scale, Flourishing scale, Scale of Positive and Negative Experience, WHO-5

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

The professional caregivers of people living with dementia at nursing homes.

Key exclusion criteria

General staffs not involved in the care for the people with dementia.

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Mitsuhiro
Middle name
Last name Ssdo

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-(0)3-5363-3971

Email

mitsusado@keio.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Ninomiya

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-(0)3-5363-3971

Homepage URL


Email

akira-ninomiya@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

KUMON INSTITUTE OF EDUCATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

+81-(0)3-3353-1211

Email

med-rinri-jimu@adst.keio.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 19 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

2272

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Due to the time required for data cleaning

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

No longer recruiting

Date of protocol fixation

2018 Year 05 Month 11 Day

Date of IRB

2018 Year 05 Month 11 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Self-administered questionnaires were collected at the beginning of the study, 6 and 12 months later, respectively.
Data cleaning is currently underway.


Management information

Registered date

2019 Year 05 Month 19 Day

Last modified on

2023 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name