UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056500 |
|---|---|
| Receipt number | R000063933 |
| Scientific Title | Research on the Establishment of a Telemedicine System for Cochlear Implant and Hearing Aid Users by Speech-Language Pathologists and Other Professionals |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/19 13:07:55 |
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Basic information
Public title
Research on the Establishment of a Telemedicine System for Cochlear Implant and Hearing Aid Users by Speech-Language Pathologists and Other Professionals
Acronym
Research on the Establishment of a Telemedicine System for Cochlear Implant and Hearing Aid Users by Speech-Language Pathologists and Other Professionals
Scientific Title
Research on the Establishment of a Telemedicine System for Cochlear Implant and Hearing Aid Users by Speech-Language Pathologists and Other Professionals
Scientific Title:Acronym
Research on the Establishment of a Telemedicine System for Cochlear Implant and Hearing Aid Users by Speech-Language Pathologists and Other Professionals
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After establishing a telemedicine system for cochlear implant and hearing aid treatment for both pediatric and adult patients, this study aims to verify the usefulness and safety of the system. Additionally, a comparative evaluation between telemedicine and face-to-face care will be conducted. By performing a detailed cost-effectiveness analysis in comparison with face-to-face care, the study will examine the positioning of telemedicine within the current healthcare insurance system and aim to present informed perspectives and future directions regarding the potential inclusion of telemedicine in insurance coverage and reimbursement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cochlear implant mapping (for cochlear implant users) and hearing aid fitting (for hearing aid users) performed and adjusted through telemedicine and face-to-face care, respectively
Key secondary outcomes
Hearing ability of users assessed through telemedicine and face-to-face care (for cochlear implant users: sound-field speech perception test using CI2004, iCI2004, and cochlear implant fitting threshold; for hearing aid users: sound-field speech perception test using the 67-S word list, 57-S word list, and hearing aid fitting threshold), along with functional evaluation metrics (questionnaire assessments such as SSQ12, SSQP, HUI).
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Week 0: In-person
In-person mapping and device adjustment at the medical institution, functional evaluation metrics, hearing ability assessment, evaluation of the utilization of medical and non-medical resources (questionnaire assessment), and distribution of the telemedicine system.
Week 2: Remote
Remote mapping and device adjustment at home, functional evaluation metrics, assessment of patient, family, and healthcare provider satisfaction (questionnaire assessment), and evaluation of the utilization of medical and non-medical resources (questionnaire assessment).
Week 4: Remote
Remote mapping and device adjustment at home, functional evaluation metrics, assessment of patient, family, and healthcare provider satisfaction (questionnaire assessment), and evaluation of the utilization of medical and non-medical resources (questionnaire assessment).
Week 6: In-person
In-person mapping and device adjustment at the medical institution, functional evaluation metrics, hearing ability assessment, evaluation of the utilization of medical and non-medical resources (questionnaire assessment), and collection of the telemedicine system.
Comparison of each evaluation metric between in-person and remote settings.
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
| 6 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been using a cochlear implant for more than 12 months (age 6 and above).
Patients using a cochlear implant either unilaterally or bilaterally.
Patients using the latest cochlear implants compatible with telemedicine (Cochlear Japan external devices: N5, N6, N7, KANSO).
Patients with stable mapping created during in-person care within 6 months prior to the start of this study.
Key exclusion criteria
Patients who have expressed a refusal to participate in this study.
Patients with incomplete or missing data.
Patients deemed unsuitable as study participants by the researchers due to complications or treatment progress.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Takano |
Organization
Sapporo Medical University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
0608556
Address
South 1 West 17, Chuo-ku, Sapporo,Hokkaido,Japan
TEL
011-611-2111
kent@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Sumito |
| Middle name | |
| Last name | Jitsukawa |
Organization
Sapporo Medical University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
0608556
Address
South 1 West 17, Chuo-ku, Sapporo,Hokkaido,Japan
TEL
011-611-2111
Homepage URL
sumitojjj@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya City University Hospital
Iseikai International General Hospital, Iseikai Medical Corporation
The University of Tokyo Hospital
Kyushu University Hospital
Iwate Medical University Hospital
Osaka University Hospital
Nagasaki University Hospital
Tokyo Medical Center
Kanda E.N.T. Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Support Center, Sapporo Medical University Hospital
Address
South 1 West 17, Chuo-ku, Sapporo,Hokkaido,Japan
Tel
011-611-2111
ji-rskk@sapmed.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 | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 02 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063933
