UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042126 |
|---|---|
| Receipt number | R000048080 |
| Scientific Title | Cluster randomized controlled trials of prevention in frailty through radio program for the elderly in the local community |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2024/04/18 10:31:17 |
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Basic information
Public title
Trials of prevention in frailty through radio program for the elderly in the local community
Acronym
Prevention in frailty through radio program
Scientific Title
Cluster randomized controlled trials of prevention in frailty through radio program for the elderly in the local community
Scientific Title:Acronym
Cluster randomized controlled trials of prevention in frailty through radio program
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to study an efficacy of radio program for prevention to frailty for the elderly in the local community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of simplified Japanese version of WHO five well-being index before and after 4 times of Radio Program listening.
Key secondary outcomes
Questionnaire on frailty prevention before and after 4 times of Radio Program listening.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Four times of listening of radio program about prevention of frailty group
Interventions/Control_2
Non-listening group
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
Healthy members of elderly clubs in Asahikawa city.
Key exclusion criteria
Dementia, hearing loss
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Osanai |
Organization
Asahikawa Medical University
Division name
Cardiovascular, Respiratory and Neurology Division, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa
TEL
0166-68-2837
shinobuo@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Osanai |
Organization
Asahikawa Medical University
Division name
Cardiovascular, Respiratory and Neurology Division, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa
TEL
0166-68-2837
Homepage URL
shinobuo@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-founding
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
Asahikawa Medical University
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa
Tel
0166682837
shinobuo@asahikawa-med.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 | 10 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000048080
Publication of results
Published
Result
URL related to results and publications
https://www.asahikawa-med.ac.jp/uploads/files/portal/guide/public/publication/forum21.pdf
Number of participants that the trial has enrolled
117
Results
Results showed that lifestyle inactivity increased and mental health declined due to the infection spread. No significant mental health differences were observed between the groups. The study concluded that radio listening had a limited effect on preventing lifestyle inactivity and health impacts.
Results date posted
| 2024 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
elderly members of senior clubs
Participant flow
Conducted in October and November 2020, the research targeted elderly members of senior clubs, dividing them into an intervention group, which received information about radio broadcasts, and a control group that did not.
Adverse events
None
Outcome measures
The study involved initial and follow-up surveys to assess changes in participants' lifestyles and mental health status.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048080
