UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042127 |
|---|---|
| Receipt number | R000048082 |
| Scientific Title | Research on methods for promoting social participation of hearing-impaired people |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2024/04/10 08:50:12 |
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Basic information
Public title
Research on methods for promoting social participation of hearing-impaired people
Acronym
Research on methods for promoting social participation of hearing-impaired people
Scientific Title
Research on methods for promoting social participation of hearing-impaired people
Scientific Title:Acronym
Research on methods for promoting social participation of hearing-impaired people
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To promote social participation of hearing-impaired people
Basic objectives2
Others
Basic objectives -Others
Social implementation of support for the hearing impaired and recommendation for social policy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social participation of hearing-impaired people
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of self-advocacy textbooks
Interventions/Control_2
Employment support with intervention in business establishments
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Children and adults with hearing impairment
Key exclusion criteria
Patients who cannot participate in research due to multiple disorders, etc
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Kyushu University, Faculty of Medical Sciences
Division name
Department of Otolaryngology
Zip code
8128582
Address
3-1-1, Maidashi, Fukuoka
TEL
0926425668
nakataka@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Noda |
Organization
Kyushu University, Faculty of Medical Sciences
Division name
Department of Otolaryngology
Zip code
8128582
Address
3-1-1, Maidashi, Fukuoka
TEL
0926425668
Homepage URL
teppei@med.kyushu-u.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Kyushu University IRB
Address
3-1-1, Maidashi, Fukuoka
Tel
0926425774
byskenkyu@jimu.kyushu-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
九州大学病院（福岡県）、岡山大学病院（岡山県）、東京医療センター（東京都）、札幌医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
no data
Publication of results
Published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202002262212158133
Number of participants that the trial has enrolled
63
Results
A Japanese version of self-advocacy checklist was created. Using this checklist, we examined the current status of self-advocacy in Japan and the usefulness of the checklist. The results showed that 1) scores increased with grade, but only 20% of the students reached the "proficient" level even in the upper grades, and 2) the acquisition rate by grade varied depending on the item.
Results date posted
| 2023 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hearing impaired children attending a rehabilitation facility participated in the study. Elementary school students were targeted.
Participant flow
Written consent was obtained from the attending hearing-impaired children and their parents for inclusion. Those who met the exclusion criteria were excluded.
Adverse events
none
Outcome measures
Total points on the Self-Advocacy Checklist and each assessment item
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Due to the spread of COVID-19, cooperation from the schools for the deaf and others targeted for the study was not obtained, and the study did not progress.
Management information
Registered date
| 2020 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048082
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
