NCT07146607

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

August 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

August 21, 2025

Last Update Submit

March 5, 2026

Conditions

Keywords

hearing losshearing aidhealth behaviour

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

EXPERIMENTAL

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)).

Behavioral: Audiology text-message protocol

Standard audiological care (treatment as usual)

NO INTERVENTION

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.

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).

Hearing aids plus text-message protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (3)

QMC Ropewalk House

Nottingham, Nottinghamshire, NG1 5DU, United Kingdom

ENROLLING BY INVITATION

Sunderland Royal Hospital, Kayll Road, Sunderland, SR4 7TP

Sunderland, SR4 7TP, United Kingdom

RECRUITING

Audiology Department Suite 2 Thomas Linacre Centre Parsons Walk Wigan WN1 1RU

Wigan, WN1 1RU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emma E Broome, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

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
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study
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

Locations