Evaluating an Audiology Text-Message Protocol to Support Hearing Aid Use in NHS Adult Audiology Patients
Audiology Text-Messaging Intervention (Florence) to Improve Hearing Aid Use in NHS Adult Audiology Patients: A Feasibility Study With Proof-of-Concept and Embedded Process Evaluation
1 other identifier
interventional
70
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 9, 2026
March 1, 2026
1.1 years
August 21, 2025
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Self-reported hearing aid use
A bespoke single item question recording the self-reported average hours of daily hearing aid use over the past seven days. The question "On a typical day over the last seven days, how many hours did you use your hearing aid?" will be collected via participants' preferred contact method.
From enrollment to week 16 and 28
Glasgow Hearing Aid Benefit Profile (GHABP): (Gatehouse 1999)
The GHABP is a 24-item scale consisting of six subscales. The subscales address hearing aid initial disability, hearing aid handicap, reported hearing aid use, reported hearing aid benefit, hearing aid satisfaction and hearing aid derived benefit. Each domain is measured on a five-point scale, and the mean score across four predefined situations is converted into a percentage. Participants will only be asked to complete Part A (preintervention) of the GHABP questionnaire at the baseline assessment (pre-hearing aid fitting). Part B (residual) will be completed at the 16 and 28 week follow up (post-hearing aid fitting).
Week 1 (Part A) Week 16, 28 (Part B)
Secondary Outcomes (16)
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A): (Ventry and Weinstein 1982)
Week 1, Week 16, 28
Auditory Lifestyle and Demand questionnaire (ALDQ): (Gatehouse 1999)
Week 1, Week 16, 28
International Outcome Inventory for Hearing Aids (IOI-HA) (Cox and Alexander 2002)
Week 16, 28
Hearing Related Lifestyle (HEARLI-Q) (Lelic, Wolters et al. 2022)
Week 16, 28 Week 1, Week 16, 28
Hearing related adaptive strategies (AStra) (Fischer 2024)
Week 1, Week 16, 28
- +11 more secondary outcomes
Study Arms (2)
Hearing aids plus text-message protocol
EXPERIMENTALAudiology 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)).
Standard audiological care (treatment as usual)
NO INTERVENTIONParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Registered on a pre-existing Florence text-messaging protocol.
- Unable to read/understand English
- 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
- Registered on a pre-existing Florence text-messaging protocol.
- Unable to read/understand English
- Aged ≥18 years (no upper age limit)
- Able and willing to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- WSAUD A/Slead
- National Institute for Health Research, United Kingdomcollaborator
- University of Nottinghamcollaborator
Study Sites (3)
QMC Ropewalk House
Nottingham, Nottinghamshire, NG1 5DU, United Kingdom
Sunderland Royal Hospital, Kayll Road, Sunderland, SR4 7TP
Sunderland, SR4 7TP, United Kingdom
Audiology Department Suite 2 Thomas Linacre Centre Parsons Walk Wigan WN1 1RU
Wigan, WN1 1RU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma E Broome, PhD
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinding
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Fellow
Study Record Dates
First Submitted
August 21, 2025
First Posted
August 28, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03