Menu
Recruiting NCT07146607

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

No phase Interventional Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Audiology text-message protocol.
Who it may be relevant to
Registry conditions: Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

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.

Interventions

  • Behavioral 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).

Primary outcome measures

  • Self-reported hearing aid use [Time frame: From enrollment to week 16 and 28]
  • Glasgow Hearing Aid Benefit Profile (GHABP): (Gatehouse 1999) [Time frame: Week 1 (Part A) Week 16, 28 (Part B)]
Secondary outcome measures (12)
  • Hearing Handicap Inventory for the Elderly/Adults (HHIE/A): (Ventry and Weinstein 1982) [Time frame: Week 1, Week 16, 28]
  • Auditory Lifestyle and Demand questionnaire (ALDQ): (Gatehouse 1999) [Time frame: Week 1, Week 16, 28]
  • International Outcome Inventory for Hearing Aids (IOI-HA) (Cox and Alexander 2002) [Time frame: Week 16, 28]
  • Hearing Related Lifestyle (HEARLI-Q) (Lelic, Wolters et al. 2022) [Time frame: Week 16, 28 Week 1, Week 16, 28]
  • Hearing related adaptive strategies (AStra) (Fischer 2024) [Time frame: Week 1, Week 16, 28]
  • Big Five Inventory (BFI) (John 1991) [Time frame: Week 1]
  • Short Assessment of Patient Satisfaction (SAPS) (Hawthorne, Sansoni et al. 2014) [Time frame: Week 1, 28]
  • Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA): (West and Smith 2007) [Time frame: Week 1, Week 16, 28]
  • Short Form Patient Activation Measure (PAM) (Hibbard, Mahoney et al. 2005) [Time frame: Week 1, 3, 16, 28]
  • Empowerment Audiology Questionnaire (EmpAQ-15) (Bennett, Larsson et al. 2024) [Time frame: Week 1, 3, 16, 28]
  • Expected Consequences of Hearing aid Ownership (ECHO): (Cox and Alexander 2000) [Time frame: Week 1, 3, 16, 28]
  • Stigma Consciousness Questionnaire for Hearing Loss (SCQ-HL): (Vincent, Gagné et al. 2017) [Time frame: Week 1, 16, 28]

Eligibility criteria

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)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Kingdom · 3 centers
  • 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

Identifiers

NCT: NCT07146607 · IRAS 345347

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗