UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040335 |
|---|---|
| Receipt number | 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 | 2022/09/27 13:43:08 |
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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
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
shinohara-t@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045960
