UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056063 |
|---|---|
| Receipt number | R000063757 |
| Scientific Title | The behavioral impact of sharing information on the implementation of oral function training through personal health records: a randomized controlled trial |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/05 18:28:18 |
* 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
The behavioral impact of sharing information on the implementation of oral function training through personal health records: a randomized controlled trial
Acronym
The behavioral impact of sharing information on the implementation of oral function training through personal health records: a randomized controlled trial
Scientific Title
The behavioral impact of sharing information on the implementation of oral function training through personal health records: a randomized controlled trial
Scientific Title:Acronym
The behavioral impact of sharing information on the implementation of oral function training through personal health records: a randomized controlled trial
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether greater behavioural change can be achieved by sharing the results of oral exercises to maintain and improve the oral function of the elderly with a close person using a smartphone app and receiving feedback
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of times the "Patakara exercise" was performed in the seven days from 29 to 35 days after the start of the study
Key secondary outcomes
Changes in the following items from the start to the end of the study
-DASC-21
-"12 items related to frailty"
-Chewing strength
-Oral dryness
-Number of times the "Patakara exercise" can be done in 5 seconds
-Results of the questionnaire on oral condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants in the intervention group will be asked to carry out and record oral exercises using a smartphone app, and to share the status of their oral exercise implementation with their partner via the app. The partner will also be asked to provide feedback based on the implementation status twice a week via the app. The intervention period will be four weeks from the start of the study, and no feedback will be provided by the partner during the outcome measurement period (days 29 to 35 after the start of the study).
Interventions/Control_2
The participants in the control group will be asked to carry out and record oral exercises using a smartphone app, but they will not share the status of their oral exercise implementation with their partner or receive feedback from their partner.
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
The following conditions must all be met
-65 years of age or older
-using a smartphone with an operating system of iOS 11.0 / Android 5.1 or higher
-be able to get the cooperation of a family member or friend (partner) who is using a smartphone that meets the above conditions
-a native speaker of Japanese
Key exclusion criteria
-with dementia
-have already been diagnosed with oral hypofunction by a dentist
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
School of Public Health, Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services
Zip code
606-8315
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757534400
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Ikeuchi |
Organization
School of Public Health, Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services
Zip code
606-8315
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757534400
Homepage URL
oral_trial@yobou.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Healthtech Laboratory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
C1691
Org. issuing International ID_1
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
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 | 11 | Month | 05 | 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
| 2024 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063757
