Feasibility of a RCT of the ACE programme
Research type
Research Study
Full title
Feasibility of a RCT of the Active Communication Education (ACE) programme plus hearing aid provision versus hearing aid provision alone.
IRAS ID
204072
Contact name
Nicholas J Thyer
Contact email
Sponsor organisation
Bradford Teaching Hospitals Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Hearing-impairment affects 10 million people in the UK, 70% over the age of 70. It can lead to loneliness, isolation, social withdrawal and reduced quality-of-life. The usual treatment is to fit hearing-aids. But, approximately 1 in 3 people fitted with hearing-aids struggle to use them, finding them ineffective. Research indicates interventions like the Active Communication Education (ACE) programme help patients and family members develop and use better communication strategies, increases hearing aid use and benefit gains commonly reported by successful hearing-aid users. In this study we will test the feasibility of a future large randomised control trial of the ACE plus a hearing aid, versus a hearing aid alone to rigorously test these assertions.
This two year feasibility study will involve 112 new NHS adult hearing-aid users who are struggling with their hearing-aid. We will recruit participants attending routine hearing-aid follow-up appointments at two audiology departments; in York and Bradford. Half will be randomly assigned to ACE with a family member the remainder will continue with usual treatment. ACE comprises five, two hour, weekly group sessions delivered in each department by a study audiologist. The programme teaches participants solutions to everyday situations where communication is difficult, such as conversing in background noise; communication with difficult speakers.
Outcomes (questionnaires) will measure changes in communication, hearing-aid benefit and quality-of-life and the acceptability of study processes and healthcare resource use as a consequence of attending ACE. We will test processes associated with delivering ACE in this NHS context, and other study delivery processes, recording data about recruitment, randomisation, administering outcome measures and any associated burden. Finally we will interview a sample of audiologists and participants to fully understand their experience of participation. Study outcomes will be used to inform the design of a larger future randomised control trial of the ACE.REC name
London - Surrey Research Ethics Committee
REC reference
16/LO/2012
Date of REC Opinion
2 Dec 2016
REC opinion
Further Information Favourable Opinion