Evaluating an Audiology Text-Message Protocol to Support Hearing Aid Use in NHS Adult Audiology P… (NCT07146607) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating an Audiology Text-Message Protocol to Support Hearing Aid Use in NHS Adult Audiology Patients
United Kingdom70 participantsStarted 2025-09-30
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported hearing aid use
Timeframe: From enrollment to week 16 and 28
2
Glasgow Hearing Aid Benefit Profile (GHABP): (Gatehouse 1999)