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

WS Audiology (WSAUD)

Status: Begins enrollment this month

Conditions: Hearing Loss

Treatments: Behavioral: Audiology text-message protocol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07146607

IRAS 345347

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Hearing aids plus text-message protocol

Experimental group

Description:

Audiology text-message protocol: The experimental group will receive a minimum of 65 text-messages directly to their mobile telephone for the duration of the 14-week text-message protocol (2 weeks for Stage 1 protocol, 12 weeks for Stage 2 protocol) in addition to receiving the standard audiology treatment as usual (see Control: Standard audiological care (hearing aid provision - treatment as usual)).

Treatment:

Behavioral: Audiology text-message protocol

Standard audiological care (treatment as usual)

No Intervention group

Description:

Participants allocated to the control group will receive treatment as usual. Treatment as usual is defined as standard treatment available to NHS audiology patients. This may include an audiological assessment, prescription of one/two hearing aids, and an optional face-to-face follow-up appointment.