NCT07146607 Evaluating an Audiology Text-Message Protocol to Support Hearing Aid Use in NHS Adult Audiology Patients
| NCT ID | NCT07146607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | WSAUD A/S |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-09-30 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Emma E Broome, PhD
PRINCIPAL INVESTIGATOR
University of Nottingham
Frequently Asked Questions
Who can join the NCT07146607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146607 currently recruiting?
Yes, NCT07146607 is actively recruiting participants. Contact the research team at emma.broome1@nottingham.ac.uk for enrollment information.
Where is the NCT07146607 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom, Sunderland, United Kingdom, Wigan, United Kingdom.
Who is sponsoring the NCT07146607 clinical trial?
NCT07146607 is sponsored by WSAUD A/S. The principal investigator is Emma E Broome, PhD at University of Nottingham. The trial plans to enroll 70 participants.