UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047743 |
|---|---|
| Receipt number | 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 | 2024/06/26 11:54:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yukimck@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
https://doi.org/10.20685/kenkouigaku.32.1_89
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.20685/kenkouigaku.32.1_89
Number of participants that the trial has enrolled
34
Results
A 90-minute program was conducted once a month for a total of three sessions. The results showed that the proportion of participants who weighed themselves almost every day was significantly higher after the intervention than before. No significant changes in nutritional status were observed before and after the intervention, but BMI was significantly lower after the intervention than before in the subjects as a whole and in the late-aged subjects.
Results date posted
| 2024 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seniors 65 years of age or older residing in the community
Participant flow
We posted an advertisement on the bulletin board of apartment complex B in City A, and at the same time, requested the cooperation of the residents' association.
Adverse events
No adverse events
Outcome measures
The frequency of daily self-weight measurements, anthropometric measurements, nutritional status, frailty index
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
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
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054174
