UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053337 |
|---|---|
| Receipt number | R000060855 |
| Scientific Title | Testing the Effectiveness of a Hearing Loss Care Education Program for Visiting Nurses of Older Adults with Hearing Loss |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2025/06/05 17:13:24 |
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Basic information
Public title
Testing the Effectiveness of a Hearing Loss Care Education Program for Visiting Nurses of Older Adults with Hearing Loss
Acronym
Testing the Effectiveness of a Hearing Loss Care Education Program for Visiting Nurses of Older Adults with Hearing Loss
Scientific Title
Testing the Effectiveness of a Hearing Loss Care Education Program for Visiting Nurses of Older Adults with Hearing Loss
Scientific Title:Acronym
Testing the Effectiveness of a Hearing Loss Care Education Program for Visiting Nurses of Older Adults with Hearing Loss
Region
| Japan |
Condition
Condition
Hearing Loss
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a hearing loss care education program for visiting nurses to educate them on hearing loss care for the 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
Knowledge of Hearing Loss Care
Awareness of hearing loss care implementation
Frequency of hearing loss care
Self-assessment scale for quality of home nursing care
(immediately after intervention, 1 month later, 3 months later)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Number of interventions: 2 sessions (1st session: viewing of video materials, 2nd session: group work)
Interventions: Hearing loss screening, ear canal care, hearing aid care, etc.
Interventions/Control_2
non
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Visiting nurses visiting the elderly
Key exclusion criteria
non
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sumiyo |
| Middle name | |
| Last name | Nabeshima |
Organization
Kinjo Gakuin University
Division name
Faculty of Nursing
Zip code
4638521
Address
1723-2 Oomori Moriyama-ku Nagoya
TEL
052-798-0180
nabeshima@kinjo-u.ac.jp
Public contact
Name of contact person
| 1st name | Sumiyo |
| Middle name | |
| Last name | Nabeshima |
Organization
Nagoya City University
Division name
Graduate School of Nursing
Zip code
467-8601
Address
1 kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL
052-853-8037
Homepage URL
c226805@ed.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Nabeshima Sumiyo
Funding Source
Organization
Japan Society for the Promotion of Science
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
Nagoya City University
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
Tel
052-853-8037
c226805@ed.nagoya-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 | 01 | Month | 12 | 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
102
Results
We developed an Education program for the care of hearing loss in the elderly.The results showed that the intervention was significantly effective in terms of implementation of hearing screening within the primary evaluation item implementation of hearing care with an odds ratio of 8.35 (95% confidence interval 3.60-19.34), p<0.001.
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060855
