Objective To evaluate the impact of a hearing dog partnership on the lives of individuals with severe or profound hearing loss.
Methods and Analysis A two-arm, randomised controlled trial conducted within the UK, with 162 hearing dog applicants, aged 18 years and over. Participants will be randomised 1:1 using a matched-pairs design to receive a hearing dog sooner than usual (intervention arm – Arm B) or to receive a hearing dog within the usual timeframe (comparator arm – Arm A).
In the effectiveness analysis, the primary outcome is a comparison of mental wellbeing six-months after Arm B have received a hearing dog (Arm A: not yet received hearing dog), measured using the Short Warwick Edinburgh Mental Wellbeing Scale. Secondary outcome measures include the PHQ-9, GAD-7 and WSAS.
An economic evaluation will assess cost-effectiveness including health-related quality-adjusted life years using the EQ-5D-5L and social-care-related-quality-adjusted life-years.
Participants will be followed up for up to two years. A nested qualitative study will investigate the impacts of having a hearing dog and how these impacts come about.
Results The study was funded by the National Institute for Health Research’s School for Social Care Research. Recruitment commenced in March 2017 and is now complete. 165 participants were randomised. Data collection will continue until January 2020. Results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. Ethical approval was received from the University of York’s Department of Social Policy and Social Work Research Ethics Committee (reference SPSW/S/17/1).
Conclusions The findings from this study will provide, for the first time, strong and reliable evidence on the impact of having a hearing dog on people’s lives in terms of their quality of life, well-being and mental health.
Trial registration The trial has been retrospectively registered International Standard Randomised Controlled Trial Number (ISRCTN) 36452009; https://doi.org/10.1186/ISRCTN36452009.
Trial status: Ongoing.
Bibliographical note© The Authors, 2020
- Randomised controlled trial
- Assistance Dogs
- Hearing Loss
- Health Economics
- Qualitative methods