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Protocol for a cluster randomised controlled trial comparing structured Follow-up And Monitoring Of new USers of NHS hearing aids to usual care: The FAMOUS Trial

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Title: Protocol for a cluster randomised controlled trial comparing structured Follow-up And Monitoring Of new USers of NHS hearing aids to usual care: The FAMOUS Trial
Authors: Munro, Kevin, Arden Armitage, Christopher, Elliott, Rachel, Saunders, Gabrielle, Haydock, Rebecca, Leverton, Ted, Juszczak, Edmund, Oliver, Francesca, Partlett, Christopher, Rick, Caroline, Schilder, Anne, Wild, Jane, Wilson, Paul, Sereda, Magdalena, Loughran, Michael, Holt, Grace, Gill, Bethany
Source: Munro, K, Arden Armitage, C, Elliott, R, Saunders, G, Haydock, R, Leverton, T, Juszczak, E, Oliver, F, Partlett, C, Rick, C, Schilder, A, Wild, J, Wilson, P, Sereda, M, Loughran, M, Holt, G & Gill, B 2025, 'Protocol for a cluster randomised controlled trial comparing structured Follow-up And Monitoring Of new USers of NHS hearing aids to usual care: The FAMOUS Trial.', Trials.
Publisher Information: Springer Nature, 2025.
Publication Year: 2025
Subject Terms: economic evaluation, Cluster randomised control trial, follow-up, clinical trial, protocol, hearing aid of use, behaviour change, process evaluation
Description: • Background: Hearing loss is a prevalent condition that impacts on social, mental and physical health, and has a significant economic burden. Hearing aids can improve the quality of life for those living with hearing loss; however, low and inconsistent use remains common. Within the National Health Service (NHS), follow-up care for new hearing aid users is highly variable and often lacks structure, which may contribute to low use. The FAMOUS trial investigates whether a structured care model for follow-up, combined with evidence-based behaviour change interventions, improves hearing aid use compared to usual care.• Methods: FAMOUS is a multi-centre, two-arm parallel-group cluster randomised controlled trial (CRCT) with integral internal pilot, economic and process evaluations. The trial involves 36 NHS audiology services and compares two types of follow-up for new adult hearing aid users; structured care, which includes personalised action plans, early monitoring, and routine follow-up at 6 weeks post-fitting, to usual care, which includes the offer of a follow-up 6-12 weeks after fitting. Recruitment is conducted through participating services over three months, with pseudo-anonymized routine data collected from electronic medical records of all patients who attend. Consent and outcomes are then collected from patients at 12 weeks post-fitting. For patients who provide consent to future contact, the primary outcome (self-reported daily hearing aid use) is collected at 12 months post-fitting. Secondary outcomes (quality-of-life (QoL), hearing-related disability, and economic measures) are collected at both timepoints. Qualitative interviews with a subset of patients, and hearing professionals in the intervention arm, will assess the acceptability and implementation of the intervention. Statistical analyses, including mixed-effects regression modelling, will be conducted under an intention-to-treat framework.• Discussion: FAMOUS addresses a critical evidence gap regarding the potential benefits of follow-up care for new hearing aid users. If the intervention is successful, it can be rolled out nationally using existing facilities with limited impact on resources, identified in the economic analysis, and would improve hearing aid use and quality of life for those living with hearing loss.
Document Type: Article
Language: English
ISSN: 1745-6215
Access URL: https://research.manchester.ac.uk/en/publications/2fa3cc8e-2ce9-4747-ad8b-c0ee8df7389e
Accession Number: edsair.dedup.wf.002..a62f4f03a45fd15950a759cfa6322fb4
Database: OpenAIRE
Description
Abstract:• Background: Hearing loss is a prevalent condition that impacts on social, mental and physical health, and has a significant economic burden. Hearing aids can improve the quality of life for those living with hearing loss; however, low and inconsistent use remains common. Within the National Health Service (NHS), follow-up care for new hearing aid users is highly variable and often lacks structure, which may contribute to low use. The FAMOUS trial investigates whether a structured care model for follow-up, combined with evidence-based behaviour change interventions, improves hearing aid use compared to usual care.• Methods: FAMOUS is a multi-centre, two-arm parallel-group cluster randomised controlled trial (CRCT) with integral internal pilot, economic and process evaluations. The trial involves 36 NHS audiology services and compares two types of follow-up for new adult hearing aid users; structured care, which includes personalised action plans, early monitoring, and routine follow-up at 6 weeks post-fitting, to usual care, which includes the offer of a follow-up 6-12 weeks after fitting. Recruitment is conducted through participating services over three months, with pseudo-anonymized routine data collected from electronic medical records of all patients who attend. Consent and outcomes are then collected from patients at 12 weeks post-fitting. For patients who provide consent to future contact, the primary outcome (self-reported daily hearing aid use) is collected at 12 months post-fitting. Secondary outcomes (quality-of-life (QoL), hearing-related disability, and economic measures) are collected at both timepoints. Qualitative interviews with a subset of patients, and hearing professionals in the intervention arm, will assess the acceptability and implementation of the intervention. Statistical analyses, including mixed-effects regression modelling, will be conducted under an intention-to-treat framework.• Discussion: FAMOUS addresses a critical evidence gap regarding the potential benefits of follow-up care for new hearing aid users. If the intervention is successful, it can be rolled out nationally using existing facilities with limited impact on resources, identified in the economic analysis, and would improve hearing aid use and quality of life for those living with hearing loss.
ISSN:17456215