Follow-up and monitoring of new users of NHS hearing aids

Follow-up and structured monitoring for adults offered an NHS hearing aid for the first time (FAMOUS): a cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10589817

Enrollment

10800

Registered

2022-09-01

Start date

2023-05-30

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults who present with hearing difficulties and are offered NHS hearing aid/s for the first time. Ear, Nose and Throat

Interventions

FAMOUS is a multi-centre, two-arm parallel-group Cluster Randomised Controlled Trial (CRCT). During the three-month recruitment phase, the audiology clinic’s trial allocation (usual care or enhanced

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults (=18 years) 2. Using hearing aids for first time

Exclusion criteria

Exclusion criteria: 1. Adults offered an auditory implant of any kind 2. Adults offered non-conventional hearing aids e.g., that re-route sound between ears.

Design outcomes

Primary

Measure	Time frame
Self-reported daily hearing aid use, 12 months after initial hearing aid fitting measured using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’	—

Secondary

Measure	Time frame
1. Self-reported hours of daily hearing aid use measured 12 weeks after initial hearing aid fitting, using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’ 2. Self-reported hours of daily hearing aid non-use measured 12 weeks and 12 months after initial hearing aid fitting, using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’. Non-use is defined as one hour or less per day. 3. Hearing-related quality-of-life (QoL) measured using IOI-HA survey and HHIE survey at 12 weeks and 12 months post hearing aid fitting 4. Relationships with and QoL of significant others (i.e., partner, family members) measured using SOS-HEAR questionnaire at 12 weeks and 12 months post hearing aid fitting 5. Barriers and facilitators to behaviour change within standard practice e.g., capabilities, opportunities and motivations (mechanisms of impact) measured using COM-B questionnaire at 12 weeks post hearing aid fitting 6. Experiences and acceptability of the FAMOUS enhanced care intervention to service users and service providers (process evaluation) measured using semi-structured interviews with patients, service managers and audiologists after the intervention phase has been completed at the site. 7. Estimate the cost to the NHS and value to society measured using HUI-3, HHIE and CSRI questionnaires at 12 months post hearing aid fitting	—

Measure

Time frame

1. Self-reported hours of daily hearing aid use measured 12 weeks after initial hearing aid fitting, using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’ 2. Self-reported hours of daily hearing aid non-use measured 12 weeks and 12 months after initial hearing aid fitting, using a FAMOUS-specific research question ‘In the last week, how many hours per day did you use your hearing aid, on average?’. Non-use is defined as one hour or less per day. 3. Hearing-related quality-of-life (QoL) measured using IOI-HA survey and HHIE survey at 12 weeks and 12 months post hearing aid fitting 4. Relationships with and QoL of significant others (i.e., partner, family members) measured using SOS-HEAR questionnaire at 12 weeks and 12 months post hearing aid fitting 5. Barriers and facilitators to behaviour change within standard practice e.g., capabilities, opportunities and motivations (mechanisms of impact) measured using COM-B questionnaire at 12 weeks post hearing aid fitting 6. Experiences and acceptability of the FAMOUS enhanced care intervention to service users and service providers (process evaluation) measured using semi-structured interviews with patients, service managers and audiologists after the intervention phase has been completed at the site. 7. Estimate the cost to the NHS and value to society measured using HUI-3, HHIE and CSRI questionnaires at 12 months post hearing aid fitting

—

Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026