Title: Feasibility of a RCT of the Active Communication Education (ACE) programme plus hearing-aid provision versus hearing-aid provision alone.
Funder: Department of Health and Social Care

Abstract: Aim: The aim of this study is to establish the feasibility of successfully delivering and evaluating a full-scale randomised controlled trial (RCT), including economic, acceptability and intervention fidelity components, of hearing-aid fitting alone versus hearing-aid fitting plus the Active Communication Education (ACE) programme. Background: Hearing-impairment currently affects over 10 million people in the UK. 6 million have a significant hearing-impairment and would benefit from a hearing-aid but 4 million don t access them. Of the 2 million who do, only 1.4 million are estimated to use them. Hearing-aids are linked to positive psycho-social and communication outcomes including improvements in quality-of-life. Despite the Department of Health s modernising hearing services agenda, hearing-aid use remains poor in the UK and approximately 0.6 million hearing-aid poor/non-users (and their families) are at risk for significant negative psychosocial consequences known to be related to un-treated hearing-impairment. Reasons for non-use are complex but research has identified factors relating to perceived hearing-aid benefit and situational factors. In particular, older adults who perceive greater hearing-handicap or communication difficulties, have positive attitudes and self-efficacy with respect to hearing-aid use and support from significant others, are more likely to become successful hearing-aid owners. Interventions like ACE can address these factors and there is some evidence that they lead to long or short-term improvements in communication outcomes. However, the evidence derives from a few relatively small and low quality studies and there is a need for a high quality RCT of communication programmes to establish their effectiveness. Until then, the standard NHS treatment will continue to focus on technical aspects of hearing-aid fitting without routinely addressing the additional communication needs of unsuccessful users. The NHS provides 80% of UK hearing-aids fitting > 300K devices each year; approximately 60,000 new hearing-aids remain un or under-used in England each year; an estimated direct cost of &pound;300,000 adding to additional health, education, employment, social and economic costs related to untreated hearing-impairment. Plan of Investigation: The optimal treatment-as-usual comprises two appointments for hearing&ndash;aid fitting and one three-month post-fitting follow-up appointment. Unsuccessful new hearing-aid users (and their significant other where possible) will be identified and recruited from audiology departments in Leeds and Bradford, at follow-up. They will be randomised into two groups. Two-thirds (N=56) will attend five, two-hour, weekly sessions of ACE delivered by an audiologist. One third (N=28) will receive optimal treatment-as-usual. Three outcome measures (communication function, hearing-aid use and quality-of-life) will be obtained three-months and six-months post hearing-aid fitting. Objectives are to: A) evaluate processes involved in delivering ACE: attendance and attrition rates; fidelity and acceptability of ACE to audiologists, participants and significant others; B) evaluate RCT delivery processes associated with recruitment and group accrual rates, randomisation, feasibility and acceptability of outcome measure data collection and optimizing public and patient involvement. Potential benefits to patients and the NHS: Communication-based therapeutic help is currently not routinely offered to unsuccessful NHS (or private and third sectors) hearing-aid users. Supporting communication is key to objectives set out by NHS England in their action plan on hearing loss. ACE suggests a solution as a structured, time limited communication-based intervention shown to improve hearing-impaired people s everyday communication function, as defined by the WHO. ACE has been shown to be effective and efficient to deliver in Australia and Sweden in two small studies. If we can demonstrate feasibility of a RCT of ACE as an addition to hearing-aids in a UK setting, we will be confident of successfully running a full-scale intended RCT to determine whether adding ACE to the treatment-as-usual hearing-aid pathway will lead to better communication, hearing-aid outcomes and long-lasting improvements in quality-of-life.

Lay abstract: Hearing-impairment affects 10 million people in the UK and 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 find them ineffective and struggle, needing further help to gain the potential improvements reported from hearing-aid use. Although we are aware of many reasons for unsuccessful hearing-aid use, one solution, extra communication help, is rarely provided by NHS hearing services. Communication difficulties experienced by hearing-impaired people often lead to unsuccessful hearing-aid use if they perceive the device to be of little benefit. In two small studies the Active Communication Education programme (ACE) has been shown to improve hearing-impaired adults communication. The programme teaches patients and family members solutions to everyday situations where communication is difficult, such as conversing in background noise. We want to do a large study to determine if using ACE produces long-lasting communication benefits that lead to better hearing-aid use and quality-of-life for struggling NHS adult hearing-aid users. But first, this study will test whether a larger study will work. This study will involve new hearing-aid users and a family member or friend. They will be randomly assigned (like tossing a coin) to receive the ACE programme or their usual treatment. Those in the ACE programme will attend five, two-hour, weekly sessions of ACE delivered by an audiologist. The study will see if we can measure communication, quality-of-life and hearing-aid benefit and will ask participants and clinicians what they thought of ACE. Our team has expertise in research methods and audiology to assess the possibility of successfully designing and running a large study. Research impact arising from that large study will improve clinical practice and provide significant societal and economic benefits through better patient outcomes.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: EAR