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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.

ABSTRACT: 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.

SUBMITTER: Thyer NJ

PROVIDER: S-EPMC6074637 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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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.

Thyer Nicholas J NJ Watson Jude J Jackson Cath C Hickson Louise L Maynard Christina C Forster Anne A Clark Laura L Bell Kerry K Fairhurst Caroline C Cocks Kim K Gardner Rob R Iley Kate K Gailey Lorraine L

BMJ open 20180801 7

<h4>Introduction</h4>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 pe ...[more]

PMID: 30068614

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Project description:ObjectiveTo 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.DesignRandomised controlled, open feasibility trial with embedded economic and process evaluations.SettingAudiology departments in two hospitals in two UK cities.ParticipantsTwelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.InterventionsConsenting 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 measuresThe primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.Secondary outcome measuresInternational 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.ResultsTwelve 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.ConclusionsWhile 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 numberISRCTN28090877.

Project description:ObjectiveAn instrument that facilitates the advancement of hearing healthcare delivery from a biomedical model to a biopsychosocial one that underpins the International Classification of Functioning, Disability, and Health framework (ICF) brief and comprehensive Core Sets for Hearing Loss (CSHL) is currently unavailable. The objective is to describe the process of developing and validating a new questionnaire named the HEAR-COMMAND Tool created by transferring the ICF CSHL into a theory-supported, practically manageable concept.DesignA team from Germany, the USA, the Netherlands, and Egypt collaborated on development. The following ICF domains were considered; "Body Functions" (BF), "Activities and Participation" (AP), and "Environmental Factors" (EF). The development yielded English, German, and Arabic versions. A pilot validation study with a total of 109 respondents across three countries, Germany, Egypt, and the USA was conducted to revise the item terminology according to the feedback provided by the respondents.ResultsThe questionnaire included a total of 120 items. Ninety items were designed to collect information on the functioning and 30 items inquiring about demographic information, hearing status, and Personal Factors. Except for the "Body Structures" (BS) domain, all the categories of the brief ICF CSHL were covered (a total of 85% of the categories). Moreover, the items covered 44% of the comprehensive ICF CSHL categories including 73% of BF, 55% of AP, and 27% of EF domains. Overall, the terminology of 24 ICF-based items was revised based on the qualitative analysis of the respondents' feedback to further clarify the items that were found tod be unclear or misleading. The tool highlighted the broad connection of HL with bodily health and contextual factors.ConclusionsThe HEAR-COMMAND Tool was developed based on the ICF CSHL and from multinational experts' and patients' perspectives with the aim to improve the execution of audiological services, treatment, and rehabilitation for adult patients with HL. Additional validation of the tool is ongoing. The next step would be to pair the tool with BS categories since it was excluded from the tool and determine its effectiveness in guiding hearing health care practitioners to holistically classify categories influencing hearing, communication, and conversation disability.

Project description:BackgroundCurrent evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active.Methods/designThe proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial.DiscussionThis paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain.Trial registration[ISRCTN67030896].

Dataset Information

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.

Publications

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.

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