Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR).

OBJECTIVE: To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service. DESIGN: Randomised controlled, open feasibility trial with embedded economic and process evaluations. SETTING: Audiology departments in two hospitals in two UK cities. PARTICIPANTS: Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid. INTERVENTIONS: Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group). PRIMARY OUTCOME MEASURES: The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery. SECONDARY OUTCOME MEASURES: International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible. RESULTS: Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size. CONCLUSIONS: While ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point. TRIAL REGISTRATION NUMBER: ISRCTN28090877.

Randomised controlled feasibility trial of the Active Communication Education programme plus hearing aid provision versus hearing aid provision alone (ACE to HEAR): a study protocol.

INTRODUCTION: Up to 30% of hearing aids fitted to new adult clients are reported to be of low benefit and used intermittently or not at all. Evidence suggests that additional interventions paired with service-delivery redesign may help improve hearing aid use and benefit. The range of interventions available is limited. In particular, the efficacy of interventions like the Active Communication Education (ACE) programme that focus on improving communication success with hearing-impaired people and significant others, has not previously been assessed. We propose that improved communication outcomes associated with the ACE intervention, lead to an increased perception of hearing aid value and more realistic expectations associated with hearing aid use and ownership, which are reported to be key barriers and facilitators for successful hearing aid use. This study will assess the feasibility of delivering ACE and undertaking a definitive randomised controlled trial to evaluate whether ACE would be a cost-effective and acceptable way of increasing quality of life through improving communication and hearing aid use in a public health service such as the National Health Service. METHODS AND ANALYSIS: This will be a randomised controlled, open feasibility trial with embedded economic and process evaluations delivered in audiology departments in two UK cities. We aim to recruit 84 patients (and up to 84 significant others) aged 18 years and over, who report moderate or less than moderate benefit from their new hearing aid. The feasibility of a large-scale study and the acceptability of the ACE intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews. ETHICS AND DISSEMINATION: Ethical approval granted by South East Coast-Surrey Research Ethics Committee (16/LO/2012). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters, patient forums and Trust bulletins. TRIAL REGISTRATION NUMBER: ISRCTN28090877.