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

NCT ID: NCT07146607

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding

Study Groups

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Hearing aids plus text-message protocol

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)).

Group Type EXPERIMENTAL

Audiology text-message protocol

Intervention Type BEHAVIORAL

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).

Standard audiological care (treatment as usual)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)


* 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


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

Exclusion Criteria

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


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


• Not meeting criteria for inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

WSAUD A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Emma Broome

Senior Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma E Broome, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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QMC Ropewalk House

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Emma E Broome, PhD

Role: CONTACT

+44 (0) 115 8232606

Helen Henshaw, PhD

Role: CONTACT

+44 (0) 115 8232606

Other Identifiers

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IRAS 345347

Identifier Type: -

Identifier Source: org_study_id

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