UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050615 |
|---|---|
| Receipt number | R000057653 |
| Scientific Title | Effectiveness of health education-enhanced multifactorial intervention (SAFETY on!) program to prevent falls and frailty in urban older adults living in the age of COVID-19: A randomized controlled trial |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2023/03/17 11:28:33 |
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Basic information
Public title
Effectiveness of health education-enhanced multifactorial intervention (SAFETY on!) program to prevent falls and frailty in urban older adults living in the age of COVID-19: A randomized controlled trial
Acronym
A multifactorial intervention for fall and frailty prevention in urban older adults (SAFETY on!) program: A randomized controlled trial
Scientific Title
Effectiveness of health education-enhanced multifactorial intervention (SAFETY on!) program to prevent falls and frailty in urban older adults living in the age of COVID-19: A randomized controlled trial
Scientific Title:Acronym
Effectiveness of multifactorial SAFETY on! program to prevent falls and frailty in urban older adults: A randomized controlled trial
Region
| Japan |
Condition
Condition
Older adults with age 65 years and older
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial was conducted to examine the effectiveness of the SAFETY on! program, which was developed to prevent falls in urban older adults and to evaluate its effectiveness in preventing falls and progression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of falls, injuries and progression of frailty in one year.
Key secondary outcomes
Quality of life and depression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention program is 90 minutes once a week, consists of a 30-minute mini-lecture and a 50-minute exercise program, and is provided for 4 consecutive weeks. The intervention group will receive lectures on fall prevention, nutrition, foot care, and home safety measures by doctors and nurses, and an exercise program by a health exercise instructor.
Interventions/Control_2
For the group that provides the social interaction strengthening program (control group), educational materials will not be distributed, and a tea party will be held in a small group to provide a program that promotes interaction between participants.
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
Those who meet all of the following criteria are eligible.
1) Persons who are 65 years old or older at the time of obtaining consent and live at home
2) Persons who can obtain written consent from the person to participate in this research
3) Those who are able to participate in all practical lectures and are able to visit the venue of the practical lectures
Key exclusion criteria
Those who violate any of the following will not be included in this research.
1) Subjects who have significant cognitive decline and are unable to complete the self-administered questionnaire.
2) Those who are prohibited from exercising by a physician
3) Others who are judged to be inappropriate by the chief-researcher
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamei |
Organization
Graduate School of Nursing Science, St. Luke's International University
Division name
Gerontological Nursing
Zip code
1040044
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
TEL
03-5550-2283
kamei@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamei |
Organization
10-1, Akashi-chou, Chuo-ku, Tokyo
Division name
Gerontological Nursing
Zip code
1040044
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
TEL
0355502283
Homepage URL
kamei@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Tomoko Kamei
Funding Source
Organization
Others
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
Ethics Committee of St. Luke's International University
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
Tel
03-3543-6391
kenkyukikaku@luke.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
聖路加国際大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 17 | 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
| 2023 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057653
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| Registered date | File name |
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