UMIN-CTR Clinical Trial

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	https://doi.org/10.1136/bmjopen-2020-040341
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.gerinurse.2022.08.014
Number of participants that the trial has enrolled	1953
Results	The 404 survey forms were analyzed. Decline in chewing function (beta = 0.552) and leg muscle strength weakness (beta = 0.515) were significantly associated with the change in frailty status over six months, and leg muscle strength weakness (beta = 0.512) was significantly associated over 12 months.
Results date posted	2022 Year 09 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The study will target elderly people aged 65 and over who live in local housing rather than in hospitals or aged care facilities.
Participant flow	Subjects who responded to three surveys were included in the analysis.
Adverse events	Not confirmed due to questionnaire responses.
Outcome measures	The frailty screening index, the questionnaire for medical checkup of old-old, and the questionnaire for change for life
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 08 Day
Date of IRB	2020 Year 05 Month 07 Day
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	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045960