A WhatsApp-Delivered AI-Enabled Support Programme Versus Paper-Based Support for First-Time Hearing Aid Users in Low-Resource Communities: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pretoria
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
Study Overview
Brief Summary
The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This study encompasses the following key aim:
This study aims to evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme for adults receiving preset hearing aids in low-resource community settings. The AI-enabled programme combines two complementary components delivered through the same WhatsApp channel: (i) a structured push programme of 16 voice notes and images delivered over four weeks, and (ii) an on-demand artificial-intelligence (AI) conversational support agent available throughout the four-week intervention period. The primary objective is to determine whether this WhatsApp-delivered AI-enabled programme results in superior hearing aid self-efficacy compared to receiving the equivalent core information in a paper-based pamphlet at the time of fitting. By comparing hearing aid self-efficacy, hearing aid outcomes, and user engagement between the intervention (WhatsApp AI-enabled) and control (paper-based) groups, this study seeks to establish whether AI-enabled digital delivery provides superior support and leads to better self-efficacy for first-time hearing aid users compared to traditional paper-based methods.
Detailed Description
This study aims to evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme, compared to traditional paper-based support, for adults receiving preset hearing aids in community-based settings in South Africa. The AI-enabled programme combines two complementary components delivered through the same WhatsApp channel: (i) a structured push component consisting of 16 voice notes and images sent over four weeks, covering hearing aid use, maintenance, troubleshooting, and communication strategies; and (ii) an on-demand AI conversational support agent available throughout the four-week intervention period, enabling participants to ask free-text questions and receive individualized, educationally-bounded responses. The two components are conceived as complementary: structured content delivers a planned curriculum at the right pace for acclimatization, while the AI agent answers ad-hoc questions and addresses individual concerns as they arise. We hypothesize that this WhatsApp-delivered AI-enabled intervention will result in superior hearing aid self-efficacy at five weeks post-fitting compared to receiving the equivalent core information in a paper-based pamphlet at the time of fitting.
To test this hypothesis, we will conduct a two-arm randomized controlled trial with blinded outcome assessment, in which all participants receive preset hearing aids fitted by trained community healthcare workers (CHWs). Participants will be randomly assigned to one of two groups:
- Experimental group (WhatsApp-delivered AI-enabled support): receives the AI-enabled support and acclimatization programme delivered exclusively via WhatsApp, comprising (i) 16 structured voice notes and images delivered over four weeks and (ii) on-demand access to the AI conversational support agent throughout the four-week intervention period.
- Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting.
This design compares two delivery models for hearing aid support information, a WhatsApp-delivered AI-enabled programme versus traditional paper-based provision, for first-time hearing aid users in low-resource community settings. Follow-up occurs one week after completion of the 4-week intervention. Therefore, follow-up visits to complete outcome measures will be conducted at five weeks post-fitting to ensure all experimental group participants have completed the intervention.
The primary outcome will be hearing aid self-efficacy, assessed using the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) global score at five weeks post-fitting. Secondary outcomes will include self-reported average daily use assessed using an open-ended question, self-reported hearing aid benefit, use, and satisfaction as measured by the International Outcome Inventory for Hearing Aids (IOI-HA), perceived hearing handicap assessed using the Revised Hearing Handicap Inventory - Screening (RHHI-S), hearing aid skills and knowledge assessed using the Hearing Aid Skills and Knowledge Inventory (HASKI), and social connectedness assessed using the Berkman-Syme Social Network Index (SNI). Device retention and any device-related issues will also be recorded as additional secondary outcomes. All participants will be provided with a contact number for CHWs should they require additional assistance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years and older
- •Confirmed mild to severe (20 to < 80 dB PTA in both ears) hearing loss (determined during baseline assessments)
- •Willing/available to commit to 5-week follow-up
- •Must have access to their own personal WhatsApp
- •Functional proficiency in English, isiXhosa, or Sepedi sufficient to provide informed consent and to self-complete the study outcome measures in one of these three languages, as judged by the recruiting CHW during the screening conversation.
Exclusion Criteria
- •Younger than 18 years
- •Hearing loss too severe (≥80 dB HL PTA)
- •Normal hearing (<20 dB HL PTA)
- •Middle ear pathology, such as otitis media, active drainage from the ears.
- •Unwilling/unavailable to commit to a 5-week follow-up.
- •Unilateral hearing loss
- •No access to WhatsApp/only has access via another individual's WhatsApp
- •Home language other than English, isiXhosa, or Sepedi, where the individual does not have functional proficiency in any of these three languages.
Arms & Interventions
Experimental group (WhatsApp-delivered AI-enabled support)
Experimental group (WhatsApp-delivered AI-enabled support): receives the AI-enabled support and acclimatization programme delivered exclusively via WhatsApp, comprising (i) 16 structured voice notes and images delivered over four weeks and (ii) on-demand access to the AI conversational support agent throughout the four-week intervention period.
Intervention: Go Ultra Hearing Aids (Device)
Experimental group (WhatsApp-delivered AI-enabled support)
Experimental group (WhatsApp-delivered AI-enabled support): receives the AI-enabled support and acclimatization programme delivered exclusively via WhatsApp, comprising (i) 16 structured voice notes and images delivered over four weeks and (ii) on-demand access to the AI conversational support agent throughout the four-week intervention period.
Intervention: WhatsApp-delivered AI-enabled support (Other)
Control group (paper-based support)
Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting.
Intervention: Go Ultra Hearing Aids (Device)
Control group (paper-based support)
Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting.
Intervention: Paper-Based Support Programme (Other)
Outcomes
Primary Outcomes
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
Time Frame: Five-week follow-up
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (West \& Smith, 2007) is a 24-item self-report instrument measuring four factors: (1) Basic Handling, (2) Advanced Handling, (3) Adjustment, \& (4) Aided Listening. Each item is rated on a 0-100% confidence scale in 10% increments (0% = no confidence at all, 100% = full confidence). The global score is the arithmetic mean of the 24 item responses \& ranges from 0 to 100, with higher scores indicating greater hearing aid self-efficacy. Subscale scores are calculated as the mean of the items contributing to each factor. A global score of 80% or higher is conventionally interpreted as high self-efficacy; scores below 80% indicate low to moderate self-efficacy. The MARS-HA has been translated into isiXhosa and Sepedi for use in this study; both translations underwent forward-backward translation and pilot testing for cultural equivalence (Hall et al., 2018). Participants can complete in English , isiXhosa, or Sepedi
Secondary Outcomes
- International Outcome Inventory for Hearing Aids (IOI-HA)(Five-week follow-up)
- Revised Hearing Handicap Inventory and Screening Tool (RHHI-S)(Baseline and five-week follow-up)
- Berkman-Syme Social Network Index (SNI)(Baseline and five-week follow-up)
- Hearing Aid Skills and Knowledge Inventory (HASKI-Clin)(Five-week follow-up)
Investigators
De Wet Swanepoel
Professor De Wet Swanepoel
University of Pretoria