UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057250 |
|---|---|
| Receipt number | R000065442 |
| Scientific Title | Efficacy of active learning-based health education for preventing oral frailty |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2025/09/08 17:50:05 |
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Basic information
Public title
Efficacy of active learning-based health education for preventing oral frailty
Acronym
Verification of the effectiveness of health education for preventing oral frailty
Scientific Title
Efficacy of active learning-based health education for preventing oral frailty
Scientific Title:Acronym
Verification of the effectiveness of health education for preventing oral frailty
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a health education and training program for preventing oral frailty using active learning methods for local elderly people and to verify its effectiveness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tongue pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education on oral frailty through active learning
Interventions/Control_2
Lecture-based health education on oral frailty
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Elderly people who have not been certified as needing nursing care or assistance
(2) Those who have 20 or more teeth, or those who do not have 20 or more teeth but have completed prosthetic treatment (treatment to replace teeth with artificial objects such as dentures, crowns, or bridges).
Key exclusion criteria
(1) Those who cannot take oral intake
(2) Those who are at risk of suffering from mental or physical disabilities due to participation in the study, such as cognitive disabilities, psychiatric disorders, or cerebrovascular disorders.
(3) Other individuals who the researcher deems inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | naomi |
| Middle name | |
| Last name | ran |
Organization
Kanazawa Medical University
Division name
School of Nursing
Zip code
9200293
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa
TEL
09094431552
ran@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | naomi |
| Middle name | |
| Last name | ran |
Organization
Kanazawa Medical University
Division name
School of Nursing
Zip code
9200293
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
TEL
09094431552
Homepage URL
ran@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
The Ethics Review Committee of Kanazawa Medical University
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
Tel
0762862211
crtc@kanazawa-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
| 2025 | Year | 03 | Month | 10 | 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
33
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 03 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065442
