WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users
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
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.
調査の概要
状態
条件
詳細な説明
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.
Rationale Given the limited access to hearing care in LMICs due to prohibitive costs and scarcity of trained professionals, this study leverages mHealth solutions and task-shifting to CHWs as a sustainable and scalable approach. Preliminary studies have demonstrated the feasibility of CHW-facilitated hearing aid fittings and the potential of digital support programmes to improve user outcomes. However, there is a lack of evidence from randomized controlled trials comparing digital versus traditional paper-based support in LMICs. By evaluating differences in hearing aid self-efficacy, hearing aid benefit, use, satisfaction, perceived handicap, and practical device skills, this study will provide evidence on whether mHealth-delivered support offers superior support compared to standard paper-based information.
If mHealth support demonstrates superior outcomes, it would justify scaling up digital acclimatization programmes as part of community-based hearing care models, leveraging widely available platforms such as WhatsApp to improve hearing aid success in underserved populations.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Caitlin Frisby, PhD Audiology
- 電話番号：+27 78 300 2511
- メール：caitlin.frisby@up.ac.za
研究連絡先のバックアップ
- 名前：Tersia de Kock, MA (Audiology)
- 電話番号：+27 84 514 2086
- メール：tersia@hearxfoundation.org
研究場所
-
-
Province
-
Pretoria、Province、南アフリカ、0008
- 募集
- Atteridgeville Community
-
コンタクト：
- Caitlin Frisby, PhD Audiology
- 電話番号：+27 78 300 2511
- メール：caitlin.frisby@up.ac.za
-
コンタクト：
- Tersia de Kock, MA(Audiology)
- 電話番号：+27 84 514 2086
- メール：tersia@hearxfoundation.org
-
主任研究者：
- De Wet Swanepoel, PhD Audiology
-
-
Western Cape
-
Cape Town、Western Cape、南アフリカ、7784
- 募集
- Khayelitsha Community
-
コンタクト：
- Tersia de Kock, MA (Audiology)
- 電話番号：+27 84 514 2086
- メール：tersia@hearxfoundation.org
-
コンタクト：
- Caitlin Frisby, PhD (Audiology)
- 電話番号：+27 78 300 2511
- メール：caitlin.frisby@up.ac.za
-
主任研究者：
- De Wet Swanepoel, PhD Audiology
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Go Ultras（Gohearing）は、高度なオーディオ機能、デジタルサウンド処理、Bluetooth-Streaming機能を備えた充電式のBTEプリセット補聴器です。
軽度から中程度の難聴を持つ大人向けに設計されたこれらの補聴器には、ユーザーが手動で変更して最適なリスニングの快適さを確保できる4つのユニークなプログラムがあります。
これらのデバイスには、ノイズと風の騒音の低減だけでなく、プログラムとボリュームのメモリ関数の両方があります。
Go Ultrasは、ペアあたり130ドル未満のコストで調達されます。この研究は低所得の設定で実施されるためです。
WhatsApp-delivered AI-enabled support and acclimatization programme: A pre-defined sequence of 16 voice notes and images, designed to provide clear and accessible information on the key aspects of hearing aid use, maintenance, troubleshooting, and communication strategies.
Messages are delivered on a fixed schedule, sent every second day from the time of fitting over a 30-day period, to promote engagement and to support participants during the early acclimatization period.
The voice notes and images are produced in English, isiXhosa, and Sepedi; participants receive content in the language they select at onboarding.
On-demand access to an AI-assisted conversational support agent integrated into the same WhatsApp channel.
The agent enables participants to ask free-text questions about hearing aid use, maintenance, troubleshooting, and communication strategies, and to receive individualized, educationally grounded responses.
|
|
アクティブコンパレータ：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.
|
Go Ultras（Gohearing）は、高度なオーディオ機能、デジタルサウンド処理、Bluetooth-Streaming機能を備えた充電式のBTEプリセット補聴器です。
軽度から中程度の難聴を持つ大人向けに設計されたこれらの補聴器には、ユーザーが手動で変更して最適なリスニングの快適さを確保できる4つのユニークなプログラムがあります。
これらのデバイスには、ノイズと風の騒音の低減だけでなく、プログラムとボリュームのメモリ関数の両方があります。
Go Ultrasは、ペアあたり130ドル未満のコストで調達されます。この研究は低所得の設定で実施されるためです。
Printed pamphlet.
The pamphlet covers the same content domains as Component 1 of the experimental intervention: hearing aid use, maintenance, troubleshooting, and communication tips, presented in clear and concise language with supporting illustrations.
The pamphlet includes information in English, isiXhosa, and Sepedi; participants can read the version in their preferred language.
This approach reflects current community-based fitting practice, in which information is typically provided once during the fitting session, with no structured follow-up support.
Participants retain the pamphlet and may refer to it at any time.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
時間枠：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
|
Five-week follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
時間枠：Five-week follow-up
|
The IOI-HA is a validated seven-item questionnaire to measure the effectiveness of the hearing aid intervention (Cox and Alexander, 2002).
It targets seven domains, including (i) daily use, (ii) benefit, (iii) residual activity limitations, (iv) satisfaction, (v) residual participation restrictions, (vi) impact on others, and (vii) quality of life.
Each item has five response choices, from worst to best outcome (Appendix V).
The IOI-HA has been translated into the languages most commonly used in these communities, namely isiXhosa and Sepedi.
All translated instruments underwent forward-backward translation and pilot testing for cultural equivalence (Hall et al., 2018).
The participants will have the option to complete the IOI-HA in either of these languages or in English.
The IOI-HA total score (range 7-35; higher scores indicate better hearing-aid outcomes, including use, benefit, satisfaction, and quality of life) will be measured at 5 weeks post-fitting.
|
Five-week follow-up
|
|
Revised Hearing Handicap Inventory and Screening Tool (RHHI-S)
時間枠：Baseline and five-week follow-up
|
The RHHI-S is a validated 10-item questionnaire that is a strong, unidimensional, clinically informative measure of self-perceived hearing handicap that can be used by adults of all ages (Cassarly, Matthews, Simpson, & Dubno, 2020).
Each question has three possible responses: yes, sometimes, or no.
The RHHI-S has been translated into the languages most commonly used in these communities, namely isiXhosa and Sepedi.
All translated instruments underwent forward-backward translation and pilot testing for cultural equivalence (Hall et al., 2018).
The participants will have the option to complete the RHHI-S in either of these languages or in English.
RHHI-S total score (range 0-40; higher scores indicate greater perceived hearing handicap) will be measured at baseline and 5 weeks post-fitting (Appendix VI)
|
Baseline and five-week follow-up
|
|
Berkman-Syme Social Network Index (SNI)
時間枠：Baseline and five-week follow-up
|
The SNI is a well-established tool used to assess the extent of an individual's social connections.
The SNI examines the relationship between social networks and health outcomes.
The SNI evaluates social integration by assessing four key domains: Marital status - Whether the individual is married or in a committed partnership.
Contacts with close friends and relatives - Frequency of social interactions with family and friends.
Religious group membership - Whether the individual is part of a church or religious group and attends regularly.
Participation in voluntary or community organizations - Involvement in social or civic groups outside of family and work.
The SNI assigns points based on the individual's responses to the above components.
Scores range from 0 to 4, with higher scores indicating greater social integration.
The SNI can be completed by the participants in English, isiXhosa or Sepedi
|
Baseline and five-week follow-up
|
|
Hearing Aid Skills and Knowledge Inventory (HASKI-Clin)
時間枠：Five-week follow-up
|
The HASKI is a clinician-administered questionnaire designed to evaluate the practical skills & knowledge of hearing aid users.
It covers key areas such as basic handling (insertion, removal, cleaning, & battery management), operational knowledge (using settings, adjusting controls, & troubleshooting), communication strategies (effective use in different environments), self-management (accessing resources & scheduling appointments), & care & maintenance (routine care & recognizing when professional servicing is needed).
This tool helps audiologists identify areas where users may need additional training or support, ultimately improving hearing aid outcomes & user satisfaction.
Scoring is calculated by summing the total number of items identified as competent (not problematic), dividing this by the number of items for which a response was given (i.e., excluding the "Not Applicable responses), and multiplying by 100 to give a percentage of competency.
Items are equally weighted.
|
Five-week follow-up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：De Wet Swanepoel, PhD Audiology、University of Pretoria
出版物と役立つリンク
一般刊行物
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- West RL, Smith SL. Development of a hearing aid self-efficacy questionnaire. Int J Audiol. 2007 Dec;46(12):759-71. doi: 10.1080/14992020701545898.
- Chadha S, Kamenov K, Cieza A. The world report on hearing, 2021. Bull World Health Organ. 2021 Apr 1;99(4):242-242A. doi: 10.2471/BLT.21.285643. No abstract available.
- Bisgaard N, Zimmer S, Laureyns M, Groth J. A model for estimating hearing aid coverage world-wide using historical data on hearing aid sales. Int J Audiol. 2022 Oct;61(10):841-849. doi: 10.1080/14992027.2021.1962551. Epub 2021 Aug 24.
- Arlinger S, Nordqvist P, Oberg M. International Outcome Inventory for Hearing Aids: Data From a Large Swedish Quality Register Database. Am J Audiol. 2017 Oct 12;26(3S):443-450. doi: 10.1044/2017_AJA-16-0123.
- Miola AC, Miot HA. P-value and effect-size in clinical and experimental studies. J Vasc Bras. 2021 Jul 5;20:e20210038. doi: 10.1590/1677-5449.210038. eCollection 2021. No abstract available.
- Stephens D. The International Outcome Inventory for Hearing Aids (IOI-HA) and its relationship to the Client-oriented Scale of Improvement (COSI). Int J Audiol. 2002 Jan;41(1):42-7. doi: 10.3109/14992020209101311.
- Mulwafu W, Ensink R, Kuper H, Fagan J. Survey of ENT services in sub-Saharan Africa: little progress between 2009 and 2015. Glob Health Action. 2017;10(1):1289736. doi: 10.1080/16549716.2017.1289736.
- Meyer C, Hickson L, Fletcher A. Identifying the barriers and facilitators to optimal hearing aid self-efficacy. Int J Audiol. 2014 Feb;53 Suppl 1:S28-37. doi: 10.3109/14992027.2013.832420. Epub 2014 Jan 21.
- Kelly-Campbell RJ, McMillan A. The Relationship Between Hearing Aid Self-Efficacy and Hearing Aid Satisfaction. Am J Audiol. 2015 Dec;24(4):529-35. doi: 10.1044/2015_AJA-15-0028.
- Jorbonyan A, Abolfathi Momtaz Y, Foroughan M, Mehrkian S. Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Persian Version of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (P-MARS-HA). Audiol Res. 2025 Mar 15;15(2):31. doi: 10.3390/audiolres15020031.
- Johnson CE, Jilla AM, Danhauer JL, Sullivan JC, Sanchez KR. Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. Semin Hear. 2018 May;39(2):158-171. doi: 10.1055/s-0038-1641742. Epub 2018 Jun 15.
- Hall DA, Zaragoza Domingo S, Hamdache LZ, Manchaiah V, Thammaiah S, Evans C, Wong LLN; International Collegium of Rehabilitative Audiology and TINnitus Research NETwork. A good practice guide for translating and adapting hearing-related questionnaires for different languages and cultures. Int J Audiol. 2018 Mar;57(3):161-175. doi: 10.1080/14992027.2017.1393565. Epub 2017 Nov 21.
- Fuentes-Lopez E, Fuente A, Valdivia G, Luna-Monsalve M. Does educational level predict hearing aid self-efficacy in experienced older adult hearing aid users from Latin America? Validation process of the Spanish version of the MARS-HA questionnaire. PLoS One. 2019 Dec 19;14(12):e0226085. doi: 10.1371/journal.pone.0226085. eCollection 2019.
- Frisby C, Eikelboom RH, Mahomed-Asmail F, Kuper H, Moore DR, de Kock T, Manchaiah V, Swanepoel W. Mobile Health Hearing Aid Acclimatization and Support Program in Low-Income Communities: Feasibility Study. JMIR Form Res. 2023 Aug 23;7:e46043. doi: 10.2196/46043.
- Ferguson MA, Woolley A, Munro KJ. The impact of self-efficacy, expectations, and readiness on hearing aid outcomes. Int J Audiol. 2016 Jul;55 Suppl 3:S34-41. doi: 10.1080/14992027.2016.1177214. Epub 2016 Jun 7.
- Chen J, Shen Y, Lin Q, Feng Y, Li H. Translation of Chinese version of the measure of audiologic rehabilitation self-efficacy for hearing aids and the self-efficacy among hearing aid users in China: Application of the questionnaire. PLoS One. 2025 Aug 20;20(8):e0330163. doi: 10.1371/journal.pone.0330163. eCollection 2025.
- Aazh H, Prasher D, Nanchahal K, Moore BC. Hearing-aid use and its determinants in the UK National Health Service: a cross-sectional study at the Royal Surrey County Hospital. Int J Audiol. 2015 Mar;54(3):152-61. doi: 10.3109/14992027.2014.967367. Epub 2014 Nov 14.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HUM011/0724
- 5R33DC020134 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。