Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 18, 2019
Open Peer Review Period: Jul 22, 2019 - Sep 16, 2019
Date Accepted: Jan 14, 2020
(closed for review but you can still tweet)
Partnerships between deaf people and hearing dogs (PEDRO): Protocol for a single-centre randomised superiority study to investigate the effectiveness and cost-effectiveness of receiving a hearing dog on mental wellbeing and health
ABSTRACT
Background:
People with hearing loss, particularly those who lose their hearing in adulthood, are at increased risk of social isolation, mental health difficulties, unemployment, loss of independence, risk of accidents, and impaired quality of life. In the United Kingdom (UK), a single third sector organisation provides hearing dogs (HDs), a specific type of assistance dog trained to provide sound support to people with hearing loss. These dogs may also deliver numerous psychosocial benefits to recipients. This has not previously been fully investigated.
Objective:
To evaluate the impact of a hearing dog partnership on the lives of individuals with severe or profound hearing loss.
Methods:
A two-arm, randomised controlled trial conducted within the UK, with 162 HD applicants, aged 18 years and over. Participants will be randomised 1:1 to receive a HD sooner than usual (intervention arm – Arm B) or to receive a HD 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 HD (Arm A: not yet received HD), 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 2 years. A nested qualitative study will investigate the impacts of having a HD and how these impacts come about.
Results:
The study was funded by a National Institute for Health Research School for Social Care Research grant and recruitment commenced in April 2017. Ethical approval was received from the University of York’s Department of Social Policy and Social Work Research Ethics Committee. As of July 2019, 165 participants had been randomised. Data collection will continue until March 2020. Results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants.
Conclusions:
It has been possible to successfully recruit and randomise hearing dog applicants to this trial. Clinical Trial: The trial has been retrospectively registered, International Standard Randomised Controlled Trial Number (ISRCTN) 36452009; https://doi.org/10.1186/ISRCTN36452009.
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