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CTRI Number  CTRI/2024/10/075824 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effect of Hearing Aid Usage and social support on quality of life in older individuals with hearing loss 
Scientific Title of Study   Effect of Hearing Aid Usage and Psychosocial Intervention on Quality of Life in Individuals with Age-Related Hearing Loss 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajashree Ganesh Bhat 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal. Udupi

Udupi
KARNATAKA
576104
India 
Phone  9482289866  
Fax    
Email  rajashree.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr G Kanaka 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal. Udupi

Udupi
KARNATAKA
576104
India 
Phone  9845384136  
Fax    
Email  g.kanaka@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr G Kanaka 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal. Udupi


KARNATAKA
576104
India 
Phone  9845384136  
Fax    
Email  g.kanaka@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104 
 
Primary Sponsor  
Name  Rajashree Ganesh Bhat 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi, Karnataka, India,576104 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr TMA Pai PhD scholarship  Manipal Academy of Higher Education, Manipal- 576104 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Kanaka  Kasturba Medical College and Kasturba Hospital  Room no 27,2nd Floor, Audiology OPD Clinic
Udupi
KARNATAKA 		 9845384136

g.kanaka@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H838||Other specified diseases of innerear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  The control group will be asked to use the hearing aids regularly. No intervention will be provided.  
Intervention  psychosocial intervention  A psychosocial intervention module will be developed in phase 2 of the study. The newly developed module will have components such as training, education about hearing loss, skill development, environmental modification and support (tentative). The intervention module will help hearing aid users facilitate increased hearing aid use, improve communication strategies, and modify attitudes and behavior. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  New hearing aid users, The MoCA test scores greater than 19, normal middle ear functioning, at least completed primary education (8th grade and above) 
 
ExclusionCriteria 
Details  Depression score greater than 5 on Geriatric Depression Scale, diagnosed with neurological/psychological impairment, diagnosed with PTSD, any locomotor disability of lower limbs or mobility issues, diagnosed with terminal illness 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The scores of HL-QOL (Kannada version), scores of Newly developed scale to assess the social network characteristics of hearing-impaired older adults.  Baseline assessment, follow up assessment after 3 months of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Phase 3 
Date of First Enrollment (India)   04/11/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Age-related hearing loss (ARHL) is a significant risk factor for the development of cognitive decline, which is mediated by the presence of social isolation. Hence, early detection and management of social isolation is crucial. Presently, no tools are tailored to capture social network characteristics among individuals with ARHL. Social networking is subject to cultural variations, necessitating the development of a culturally appropriate tool that captures social network characteristics among individuals with ARHL in India. Furthermore, there are limited psychosocial intervention programs targeting social network enhancement. This directs the need to develop an intervention module that promotes effective HA use and social engagement among individuals with ARHL. Hence, the present study aims to investigate the effect of hearing aid usage and psychosocial intervention on the Quality of Life (QOL) in individuals with ARHL. The study has three main objectives: 1) to develop and validate hearing loss-related social network characteristic scale and to adapt and validate the HL-QOL questionnaire in the Kannada language, 2) to develop a psychosocial intervention module to facilitate Hearing Aid (HA) use and social networking in individuals with ARHL, 3) pilot testing of the developed intervention module. 

The study will be conducted in three phases. 

Phase I: Development and validation of the following tools:

  1. To develop and validate Hearing – Loss related Social Network Characteristic Scale (HL- SNCS) - A new scale will be developed to evaluate the social network characteristics of individuals with ARHL, including size, frequency, and participation.

  2. To adapt and validate the HL – QOL questionnaire in the Kannada language - The HL-QOL questionnaire was developed by Illg et al. (2023), based on ICF for hearing impairment, which has 21 items. This questionnaire will be translated and validated in Kannada language to measure the QOL among individuals with ARHL. 

1. Development and validation of Hearing – Loss related Social Network Characteristic Scale (HL- SNCS):

A new scale will be developed to evaluate the social network characteristics of individuals with ARHL, including size, frequency, and participation.

Step 1: Item generation.

An in-depth literature review will examine the existing questionnaires and social network characteristics. Additionally, a qualitative study using a semi-structured interview will be conducted to understand the social network characteristics of individuals with ARHL. The interview will consist of predetermined questions covering daily living difficulties, social engagement, developed as a result of hearing loss and about the participant’s opinions on hearing loss treatment, management, and hearing aids. The interview will be audio recorded. The recording will be transcribed verbatim and then coded to generate themes, which will be used to develop the questionnaire. The information about hearing loss treatment, management, and hearing aids will be used during the development of the intervention module.

Step 2: Delphi method:

The Delphi process will involve three rounds to finalize the social aspect items for the questionnaire. A panel of experts, including audiologists, a psychologist, a person with ARHL, and a caregiver, will rate each item’s appropriateness on a 5-point Likert scale. Items rated 4 or 5 by 90% or more of the panelists will be approved, neutral responses by 70% will be re-rated with modifications in the following rounds, and inappropriate or less than 70% rated items will be discarded. The finalized questionnaire, tentatively called the "Hearing Loss-related Social Network Characters Scale (HL-SNCS)," will consist of 15-20 items (tentative).

Step 3: Cognitive debriefing:

The researcher will ask five individuals with ARHL to review and explain each item.


Step 4: Validation: The finalized questionnaire will be administered to a group of individuals with ARHL, who will rate each item. The researcher will also administer the Practitioner Assessment Network Typology (PANT) questionnaire to the same group to examine the convergent validity.

2. Adaptation and validation of the HL-QOL questionnaire:

The HL-QOL questionnaire was developed by Illg et al. (2023), based on ICF for hearing impairment, which has 21 items.
Step 1: Translation procedure:

  1. Preparation stage: The translation of HL-QOL to the Kannada language is based on the work of Hall et al. (2018). A document of goals to translate is created to help the translation process.

  2. Forward and backward translation: The HL-QOL questionnaire is translated from English to Kannada and back to English by two bilingual translators (Kannada – English). The researcher will explain translation objectives, purpose, and terminologies. In the end, we will have obtained one best-translated version.

       3. Committee review: A multidisciplinary committee comprising one bilingual translator, a linguist, and an audiologist is created. The committee will moderate the translation process.


Step 2: Cognitive Debriefing: The researcher will ask five individuals with ARHL to read and explain their understanding of each item in the translated questionnaire.


Step 3: Psychometric Validation: The translated HL-QOL questionnaire is given to individuals with ARHL, who will be asked to rate each item as the questionnaire is self-administered. 

Phase II: Development of a psychosocial intervention module: The intervention module is developed to help HA users facilitate increased HA use, improve communication, and modify attitudes and behavior.

Step 1: Set the objective and theoretical framework: Defining clear objectives and a theoretical framework, based on the results of Phase I,

Step 2: Evidence reviews: Conducting an extensive literature review on psychoeducation interventions to enhance social network characteristics, increase socialization, and improve HA use and satisfaction.

Step 3: Development of components: The intervention module will be developed based on the findings of the literature review and the reports from the in-depth interviews conducted during Phase I. Additionally, the psychosocial intervention module’s components will include the recommendations provided by Prieur Chaintré et al. (2024).

The tentative components include training, education, skill development, environmental modification, and support. Audiological training by listening practice involves a hierarchy of activities that gradually increase in difficulty (for example, discrimination consonants). Training on regular use of HA, and non- verbal communication skills. Education covers information about ARHL and social isolation. Skill development includes training in coping strategies and life management skills. Environmental training is about adapting to surroundings, and Individualized support training, especially support from family, relatives, and professionals will be provided by evaluating this domain.

The number and duration of sessions will be finalized based on the activities. Tentatively, there will be eight weekly sessions, each lasting 60 minutes.

Step 4: Content Validation:

Experts with over five years of experience, i.e., two audiologists, one subject matter expert - a clinical psychologist, one individual with ARHL, and one caregiver, will validate an intervention module. The module will be evaluated for design, feasibility, and acceptance using a five-point Likert rating scale. 

Phase III: Pilot testing of the intervention module: To examine the efficacy of the newly developed intervention module, it is tested on novice HA users. 

Step 1: Prescribing HA: The first step of the pilot test is to provide suitable hearing aids to those with ARHL, and then eight weeks of time is given for acclimatization. Literature suggests that acclimatization occurs between 4 (Wright & Gagne, 2021) to 8 weeks (Munro & Lutman, 2003).

Step 2: Baseline assessment: Following acclimatization, all participants will undergo baseline assessment with HL-QOL (Kannada version) and HL-SNCS questionnaires.

Step 3: Allocation: Participants were assigned to two groups using the block randomization method.

Sequence Generation: A block randomization method will be used. A total of 12 blocks with a block size of 4 and the last two blocks with a block size of 2 will be generated in Excel. CO-PI1 will list all possible permutations for these groups and assign participants to groups based on the randomized list. This procedure is done by CO-PI, who will be blinded to the outcome measure.
Allocation Concealment: The Sequentially Numbered Opaque Sealed envelopes (SNOSE) method will be used for the allocation concealment procedure.
Based on this procedure, the participants in Group 1 will receive the intervention, while Group 2 will only use HA.

Step 4: Intervention: Group 1 participants will receive eight face-to-face training sessions once a week at Kasturba Hospital Manipal, each lasting one hour. The researcher will provide the home intervention if the participant cannot visit the study site. If participants visit solely for the intervention, travel costs will be provided to the participant.

Step 5: Post Intervention assessment: After three months, all participants will have a follow-up, and both groups will attend a post-intervention assessment. The HL-QOL (Kannada version) and HL-SNCS questionnaires will be administered to evaluate changes. 

 
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