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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047743
Receipt No. R000054174
Scientific Title The effects of health education to prevent frailty in urban older adults due to the COVID-19 Epidemic
Date of disclosure of the study information 2022/05/13
Last modified on 2022/05/12

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Basic information
Public title Health education for the prevention of frailty due to the COVID-19 epidemic
Acronym Health education for the prevention of frailty due to the COVID-19 epidemic
Scientific Title The effects of health education to prevent frailty in urban older adults due to the COVID-19 Epidemic
Scientific Title:Acronym The effects of health education to prevent frailty in urban older adults due to the COVID-19 Epidemic
Region
Japan

Condition
Condition Older adults living in urban area
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effectiveness of health education in preventing frailty among urban older adults due to the COVID-19 epidemic
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of frailty after 1, 2, and 3 months of intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Health education
Interventions/Control_2 No intervention
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 Older adults who do not need assistance in activities of daily living
Key exclusion criteria People who do not agree to participate in the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Michiko
Middle name
Last name Yuki
Organization Hokkaido Unversity
Division name Faculty of Health Sciences
Zip code 060-0812
Address N12W5, Kita-ku, Sapporo, Japan
TEL 011-706-3592
Email yukimck@hs.hokudai.ac.jp

Public contact
Name of contact person
1st name Michiko
Middle name
Last name Yuki
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code 060-0812
Address N12W5, Kita-ku, Sapporo, Japan
TEL 011-706-3592
Homepage URL
Email yukimck@hs.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Tanita Health and Weight Fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization the Ethics Committee of Hokkaido University Faculty of Health Sciences
Address N12W5, Kita-ku, Sapporo, Japan
Tel 011-706-3316
Email shomu@hs.hokudai.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
2022 Year 05 Month 13 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
2022 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 05 Month 30 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054174

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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