Text-message support to help new NHS hearing aid users keep using their hearing aids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a UK pilot randomized feasibility trial comparing a Florence-delivered audiology text-message protocol to usual care for new NHS hearing aid users, with 60 participants randomized 1:1. The intervention group will receive a standardised sequence of supportive and behaviour-change text messages between appointments while the control group receives usual audiology follow-up. Primary outcomes focus on trial feasibility, with secondary measures exploring proof-of-concept effects on hearing-aid adherence, patient-reported outcomes, and cost-effectiveness, and a nested process evaluation will interview patients and clinicians. Participants must be adults prescribed their first NHS acoustic hearing aid, have access to a mobile phone, and be able to read English.

Why it matters

Who can join: the full rules

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

Where it's running

• Sunderland Royal Hospital, Kayll Road, Sunderland, SR4 7TP
  Sunderland, United Kingdom Recruiting
• Audiology Department Suite 2 Thomas Linacre Centre Parsons Walk Wigan WN1 1RU
  Wigan, United Kingdom Recruiting
• QMC Ropewalk House
  Nottingham, Nottinghamshire, United Kingdom Enrolling by invitation

Study contacts

• Principal investigator: Emma E Broome, PhD — University of Nottingham
• Study coordinator: Emma E Broome, PhD
• Email: emma.broome1@nottingham.ac.uk
• Phone: +44 (0) 115 8232606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.