UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045883 |
|---|---|
| Receipt number | R000050501 |
| Scientific Title | Development and Verification of an Oral Health Promotion E-Learning Program for Long-Term Japanese Overseas Workers : A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/10/27 |
| Last modified on | 2023/11/01 09:55:16 |
* 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
Development and Verification of an Oral Health Promotion E-Learning Program for Long-Term Japanese Overseas Workers :
A Pilot Randomized Controlled Trial
Acronym
Development and Verification of an Oral Health Promotion E-Learning Program for Long-Term Japanese Overseas Workers :
A Pilot Randomized Controlled Trial
Scientific Title
Development and Verification of an Oral Health Promotion E-Learning Program for Long-Term Japanese Overseas Workers :
A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Development and Verification of an Oral Health Promotion E-Learning Program for Long-Term Japanese Overseas Workers :
A Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
dental caries
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility and acceptability of a theory-driven oral health promotion e-learning intervention for overseas workers and the research procedures for a future controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
health behavior of using fluoride toothpaste
Key secondary outcomes
Risk perception related to oral diseases,
Self-efficacy,
Motivation for oral care,
oral-related quality of life,
Acceptance of development materials
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
e-learning materials
Interventions/Control_2
Leaflet
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
| 20 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women between the ages of 20 and 44.
Agree to participate in the whole process of this study with written consent after receiving an explanation of the study purpose and method.
Gave written informed consent prior to study enrollment.
Japanese overseas workers who will visit a wide variety of countries over the three months.
Who do not require ongoing chronic disease treatment
Key exclusion criteria
Who have received serious treatment, such as tooth extraction within a month
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | kiriko |
| Middle name | |
| Last name | sasayama |
Organization
St.Luke's International University Graduate School of Nursing
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1,Akashi-cho,Chuo-ku,Tokyo 104-0044
TEL
03-3543-6391
19dn006@slcn.ac.jp
Public contact
Name of contact person
| 1st name | kiriko |
| Middle name | |
| Last name | sasayama |
Organization
St.Luke's International University Graduate School of Nursing
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1,Akashi-cho,Chuo-ku,Tokyo
TEL
03-3543-6391
Homepage URL
19dn006@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University Graduate School of Nursing
PhD student of Global Health Nursing
Institute
Department
Personal name
Funding Source
Organization
Yamaji Fumiko Nursing education and research Fund
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Luke's International University Research Ethics Review Committee
Address
9-1,Akashi-cho,Chuo-ku,Tokyo
Tel
0355502423
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37670279/
Number of participants that the trial has enrolled
100
Results
A total of 82 participants (Intervention = 36, Control = 46) were included in the analysis.
At three months post-intervention, the intervention group was fivefold more likely than the control group to have increased the odds of the behaviour of paying attention to fluoride concentration when choosing a toothpaste. In addition, a four-fold increase was observed in the intervention group compared to the control group for the behaviour of not eating or drinking for two hours after tooth brushing.
Results date posted
| 2023 | Year | 04 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It is currently in the peer review stage
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 05 | Day |
Baseline Characteristics
As a result of randomization, there were no significant differences in sociodemographic and oral health status between the two groups
Participant flow
A total of 82 (82.8%) participants, 36 (75%) in the intervention group and 46 (90.2%) in the control group, who completed the post-test were included in the analysis. The dropout rate was 17.2%.
Adverse events
Outcome measures
Oral care knowledge test
Motivation
Behavioural skills
Self-efficacy scale for oral care
Fluoride use checklist
Oral health quality of life
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050501
