Evaluating an Audiology Text-Message Protocol to Support Hearing Aid Use in NHS Adult Audiology Patients

Официальное название

Audiology Text-Messaging Intervention (Florence) to Improve Hearing Aid Use in NHS Adult Audiology Patients: A Feasibility Study With Proof-of-Concept and Embedded Process Evaluation

Обзор

Over 18 million adults in the United Kingdom have significant hearing loss, linked to isolation, depression and comorbidities. Hearing aids are the main management option yet are frequently unused (\~23%) or used irregularly (\<40%), wasting NHS resources and reducing quality-of-life gains. Digital behaviour-change interventions can improve self-management between appointments. Florence, an NHS-endorsed text-messaging system, has been used in the management of other long-term conditions, but has not yet been applied within audiology. This study will test a standardised audiology text-message protocol, delivered via Florence, to support new NHS hearing aid users, aiming to improve adherence, outcomes, and cost-effectiveness. Outcomes assess trial feasibility (primary objective), proof-of concept for efficacy (secondary objective), and process evaluation (tertiary objective).

Подробное описание

Over 18 million adults in the UK have significant hearing loss, with prevalence and severity increasing with age. Hearing loss is a leading global cause of disability, associated with social isolation, depression, dementia, and reduced quality of life, and is more common among people with other long-term conditions such as diabetes, hypertension, and cardiovascular disease. Hearing aids are the standard clinical management, yet up to 23% of new users abandon them and \<40% use them irregularly, resulting in wasted NHS resources and prolonging hearing difficulties.

Adjusting to hearing aids is a novel health behaviour, and behaviour-change interventions informed by health psychology can empower patients to manage their care, benefiting both patients and healthcare systems. Digital interventions, such as mobile text-messaging, are cost-effective ways to provide information and support between appointments and improve self-management.

Florence, an NHS-endorsed text-messaging system, has improved self-management in long-term conditions including hypertension, diabetes, and cancer, improving patient satisfaction and cost-effectiveness. It has not yet been applied in audiology. This feasibility study will examine a standardised audiology text-message protocol, delivered via Florence, for new NHS hearing aid users, addressing trial feasibility, proof-of-concept, and process evaluation objectives. Effective use could improve hearing aid adherence, quality of life, and save the NHS millions annually.

Вмешательства

• Поведенческое Audiology text-message protocol
  Florence is an interactive text messaging service, endorsed by NHS England, designed to improve clinical outcomes for patients. An audiology text-message protocol, delivered via Florence, will prepare, inform and support new NHS hearing aid users as they are prescribed, receive, and start to use their hearing aid(s).

Первичные конечные точки

• Self-reported hearing aid use [Срок оценки: From enrollment to week 16 and 28]
• Glasgow Hearing Aid Benefit Profile (GHABP): (Gatehouse 1999) [Срок оценки: Week 1 (Part A) Week 16, 28 (Part B)]

Вторичные конечные точки (12)

• Hearing Handicap Inventory for the Elderly/Adults (HHIE/A): (Ventry and Weinstein 1982) [Срок оценки: Week 1, Week 16, 28]
• Auditory Lifestyle and Demand questionnaire (ALDQ): (Gatehouse 1999) [Срок оценки: Week 1, Week 16, 28]
• International Outcome Inventory for Hearing Aids (IOI-HA) (Cox and Alexander 2002) [Срок оценки: Week 16, 28]
• Hearing Related Lifestyle (HEARLI-Q) (Lelic, Wolters et al. 2022) [Срок оценки: Week 16, 28 Week 1, Week 16, 28]
• Hearing related adaptive strategies (AStra) (Fischer 2024) [Срок оценки: Week 1, Week 16, 28]
• Big Five Inventory (BFI) (John 1991) [Срок оценки: Week 1]
• Short Assessment of Patient Satisfaction (SAPS) (Hawthorne, Sansoni et al. 2014) [Срок оценки: Week 1, 28]
• Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA): (West and Smith 2007) [Срок оценки: Week 1, Week 16, 28]
• Short Form Patient Activation Measure (PAM) (Hibbard, Mahoney et al. 2005) [Срок оценки: Week 1, 3, 16, 28]
• Empowerment Audiology Questionnaire (EmpAQ-15) (Bennett, Larsson et al. 2024) [Срок оценки: Week 1, 3, 16, 28]
• Expected Consequences of Hearing aid Ownership (ECHO): (Cox and Alexander 2000) [Срок оценки: Week 1, 3, 16, 28]
• Stigma Consciousness Questionnaire for Hearing Loss (SCQ-HL): (Vincent, Gagné et al. 2017) [Срок оценки: Week 1, 16, 28]

Критерии участия

WP1: Pilot Feasibility Study (n=60, 30 per group intervention/control (treatment as usual)) Inclusion criteria

• Aged ≥18 years (no upper age limit)
• Prescribed their first NHS acoustic hearing aid(s) for the primary concern of hearing loss
• Able and willing to provide informed consent
• Not currently participating in similar research
• Access to a mobile device (This is not required to be a smart phone device)

Критерии исключения

• Registered on a pre-existing Florence text-messaging protocol.
• Unable to read/understand English

WP2: Nested Process Evaluation (minimum n=10 patients, n=2 clinicians) Inclusion criteria (patients)

• Aged ≥18 years (no upper age limit)
• Prescribed their first NHS acoustic hearing aid(s) for the primary concern of hearing loss
• Able and willing to provide informed consent

Exclusion criteria (patients)

• Registered on a pre-existing Florence text-messaging protocol.
• Unable to read/understand English

Inclusion criteria (clinicians)

• Aged ≥18 years (no upper age limit)
• Able and willing to provide informed consent

Exclusion criteria (clinicians)

• Not meeting criteria for inclusion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 3 центра

• QMC Ropewalk House — Nottingham
• Sunderland Royal Hospital, Kayll Road, Sunderland, SR4 7TP — Sunderland
• Audiology Department Suite 2 Thomas Linacre Centre Parsons Walk Wigan WN1 1RU — Wigan

Идентификаторы

NCT: NCT07146607 · IRAS 345347

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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