CTRI Number |
CTRI/2022/11/047437 [Registered on: 18/11/2022] Trial Registered Prospectively |
Last Modified On: |
18/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Factors Enabling Hearing Aid Usage |
Scientific Title of Study
|
Exploring Factors Enabling Hearing Aid Usage: Perspectives of Hearing Aid Users And Audiologists |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Maria Jose |
Designation |
PG Student |
Affiliation |
Manipal College of Health Professions |
Address |
Department of Speech and Hearing
Manipal college of Health Professions
MAHE Manipal
Udupi KARNATAKA 576104 India |
Phone |
9535526569 |
Fax |
|
Email |
maria.jose3@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr Archana G |
Designation |
Associate Professor |
Affiliation |
Manipal College of Health Professions |
Address |
Department of Speech and Hearing
Manipal College of Health Professions
MAHE Manipal
Udupi KARNATAKA 576104 India |
Phone |
9986516039 |
Fax |
|
Email |
archana.maiya@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Archana G |
Designation |
Associate Professor |
Affiliation |
Manipal College of Health Professions |
Address |
Department of Speech and Hearing
Manipal College of Health Professions
MAHE Manipal
KARNATAKA 576104 India |
Phone |
9986516039 |
Fax |
|
Email |
archana.maiya@manipal.edu |
|
Source of Monetary or Material Support
|
Department of Speech and Hearing, Manipal College of Health Professions, Kasturba Medical College, Manipal |
|
Primary Sponsor
|
Name |
Maria Jose |
Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Maria Jose |
Manipal College of Health Professions |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka Udupi KARNATAKA |
9535526569
maria.jose3@learner.manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Medical College and Kasturba Hospital Institutional Ethic Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: H908||Mixed conductive and sensorineuralhearing loss, unspecified, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
95.00 Year(s) |
Gender |
Both |
Details |
Hearing aid users (Group 1)
Adults who are hearing aid users (age 18 and above)
Both males and females
Hearing aid users have been using digital hearing aids for more than 6 months
Audiologists (Group 2)
Audiologists who have a minimum of two years of experience
|
|
ExclusionCriteria |
Details |
Participants should not be suffering from any significant medical issues. |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
To explain the factors that promote hearing aid usage among individuals with hearing impairment based on the hearing aid user and audiologist perspective. |
30 to 45 minutes for interview
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To develop counseling tool for hearing aid adoption |
1 week |
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/11/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Aim of the study: To know the aspects that favour usage of hearing aid among individuals with hearing impairment as per views of the hearing aid user and audiologist
Objective(s) of the study 1) To explore the aspects that favoured hearing aid usage among individuals with hearing impairment based on hearing aid user’s and audiologist’s perspective. Study design: Descriptive qualitative research Need for the study: Despite the prevalence of hearing loss being high, there is reluctance seen in hearing aid adoption, especially in developing countries. Among hearing aid users the aspects that helped them adopt a hearing aid and continue the hearing aid usage is to be delved into especially in an Indian context. Procedure The study will be carried out in an interview mode. The preferred interview mode is face to face interaction, in case a pandemic wave arises the interview will be shifted to telephonic or virtual mode with adherence to Covid 19 guidelines. Participants will be explained the details of the study and informed consent will be obtained for the audio recording of the verbatim before proceeding with a face-to-face interview mode. The researcher will ask the participants to explain the reasons for hearing aid adoption and its usage and the verbatim of the participant is recorded. The questions asked are open-ended questions to get a descriptive statement from the participants. Similarly, the audiologists are also asked questions based on their perspectives on hearing aid adoption and usage among clients. |