FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H908||Mixed conductive and sensorineuralhearing loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
Close