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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040335
Receipt No. R000045960
Scientific Title Impacts of COVID-19 on frailty in community-dwelling older adults; a cross-sectional and cohort study
Date of disclosure of the study information 2020/05/08
Last modified on 2020/05/08

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Basic information
Public title Impacts of COVID-19 prevention life in community-dwelling older adults and support measures
Acronym Impacts of COVID-19 prevention life in community-dwelling older adults
Scientific Title Impacts of COVID-19 on frailty in community-dwelling older adults; a cross-sectional and cohort study
Scientific Title:Acronym Impacts of COVID-19 on frailty in community-dwelling older adults; a cross-sectional study
Region
Japan

Condition
Condition frailty
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the impact of COVID-19 prevention on frailty in the community-dwelling older adults.
Basic objectives2 Others
Basic objectives -Others To clarify the effect of support measures using frail screening.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Frailty Screening Index
Key secondary outcomes Questionnaire for the elderly

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria No setting
Key exclusion criteria subejct who did not get consent
Target sample size 346

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Shinohara
Organization Takasaki University of Health and Welfare
Division name Faculty of Health Care
Zip code 370-0033
Address 501, Naka Orui-machi, Takasaki-shi, Gunma
TEL 0273521291
Email shinohara-t@takasaki-u.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Shinohara
Organization Takasaki University of Health and Welfare
Division name Faculty of Health Care
Zip code 370-0033
Address 501, Naka Orui-machi, Takasaki-shi, Gunma
TEL 0273521291
Homepage URL
Email shinohara-t@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, Takasaki University of Health and Welfare
Address 501, Naka Orui-machi, Takasaki-shi, Gunma
Tel 0273521290
Email mune@takasaki-u.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
2020 Year 05 Month 08 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
2020 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 08 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Local volunteers distribute the survey forms to community-dwelling older adults.The answers will be collected by mail after signing the consent on the survey forms.It will start in May 2021 and conduct a similar survey every six months for one year to June 2022.

Management information
Registered date
2020 Year 05 Month 08 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045960

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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