UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055191 |
|---|---|
| Receipt number | R000063058 |
| Scientific Title | Development of an Oral Health Literacy and Oral Function Maintenance and Improvement Program for the Elderly at Home in the Community |
| Date of disclosure of the study information | 2024/08/08 |
| Last modified on | 2025/02/06 09:09:14 |
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Basic information
Public title
Development of an Oral Health Literacy and Oral Function Maintenance and Improvement Program for the Elderly at Home in the Community: A Pilot Study with Pre-and Post-Comparison Design
Acronym
Development of an Oral Health Literacy and Oral Function Maintenance and Improvement Program for the Elderly at Home in the Community
Scientific Title
Development of an Oral Health Literacy and Oral Function Maintenance and Improvement Program for the Elderly at Home in the Community
Scientific Title:Acronym
Development of an Oral Health Literacy and Oral Function Maintenance and Improvement Program for the Elderly at Home in the Community
Region
| Japan |
Condition
Condition
Oral Health
Classification by specialty
| Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop oral health literacy and oral health care education program for older adults and to determine the effectiveness of the program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral dryness
Masticatory function
Tongue and lip motor function
Tongue pressure
Pulmonary function
Oral health literacy
Swallowing functio
Immediately after intervention, 1 month, 3 months, 6 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Oral Function Improvement Training
Oral Health Care Education
Interventions/Control_2
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
Aged 65 and over at living in home
People who can perform oral training by themselves
People whose physical functions and oral conditions (no inflammation, condition of teeth and gums, etc.) are in good health (including those who wear dentures)
People who can express their own sensations and impressions
People who, after receiving a thorough explanation of the study and with sufficient understanding, have given their consent in writing of their own free will to participate in the study
Key exclusion criteria
People who have been diagnosed with dementia by a medical institution
People with removable dental implants or dental fillings that can be easily removed.
People with cervical or facial diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Fujimura |
Organization
Ehime University
Division name
Graduate School of Medicine
Zip code
791-0295
Address
454, Shitsukawa, Toon-city, Ehime
TEL
0899605403
fujimura.kazumi.ox@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Fujimura |
Organization
Ehime University
Division name
Graduate School of Medicine
Zip code
791-0295
Address
454, Shitsukawa, Toon-city, Ehime
TEL
0899605403
Homepage URL
fujimura.kazumi.ox@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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
Ehime University
Address
454, Shitsukawa, Toon-city, Ehime
Tel
0899605403
fujimura.kazumi.ox@ehime-u.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
| 2024 | Year | 08 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063058
