Comparing mental well-being of people with hearing loss who have been partnered with a hearing dog to those that have applied for, but not yet received a hearing dog

A randomised controlled trial investigating the impact of receiving a hearing dog on recipient well-being

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36452009

Enrollment

162

Registered

2019-02-06

Start date

2017-04-01

Completion date

Unknown

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing loss Ear, Nose and Throat

Interventions

The randomisation is being conducted centrally by York Trials Unit. Block randomisation, with a block size of 2, is being used to allocate participants 1:1 to ether arm A or arm B. The allocation sc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Any adult aged 18 living in the United Kingdom who meets the criteria to be eligible to apply for their first hearing dog 2. They must have severe or profound hearing loss

Exclusion criteria

Exclusion criteria: 1. Individuals who do not reach the criteria to be eligible for a hearing dog 2. Individuals aged 17 yrs or younger 3. Individuals requiring a dog who can provide sound and vision support 4. Individuals who are replacing a retiring hearing dog or have already had a hearing dog 5. Individuals with learning disability (indicated by use of proxy during application process)

Design outcomes

Primary

Measure	Time frame
Mental wellbeing measured using the Short Warwick Edinburgh Mental Well-being Scale at the following timepoints: T0-1 (Baseline) acceptance of application by Hearing Dogs for Deaf People T0 Point of randomisation T1 Primary timepoint: Six months' post-receipt of hearing dog - comparator no dog T2 12 months' post receipt of hearing dog - comparator no dog (where applicable) T3 18 months' post receipt of hearing dog. Intervention arm only T4 24 months' post receipt of hearing dog. Intervention arm only	—

Measure

Time frame

Mental wellbeing measured using the Short Warwick Edinburgh Mental Well-being Scale at the following timepoints: T0-1 (Baseline) acceptance of application by Hearing Dogs for Deaf People T0 Point of randomisation T1 Primary timepoint: Six months' post-receipt of hearing dog - comparator no dog T2 12 months' post receipt of hearing dog - comparator no dog (where applicable) T3 18 months' post receipt of hearing dog. Intervention arm only T4 24 months' post receipt of hearing dog. Intervention arm only

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Secondary

Measure	Time frame
All secondary outcomes are being collected at the same time points as the primary outcomes. (T0-1 on application to Hearing Dogs for Deaf People, T0 on randomisation, T1 6 months after Arm B participant has received dog, T2 12 months after Arm B participant has received dog, T3 18 months after Arm B participant has received dog, T4 24 months after Arm B participant has received dog). Only participants who received their dog before July 2018 will be eligible to receive T3/T4 questionnaires). 1. Quality of Life measured using EQ5D 2. Anxiety measured using GAD7 3. Depression measured using PHQ9 4. Impairment in functioning using WSAS 5. Problems associated with hearing impairment which a hearing dog is meant to alleviate, measured using the Hearing Dog Questionnaire	—

Measure

Time frame

All secondary outcomes are being collected at the same time points as the primary outcomes. (T0-1 on application to Hearing Dogs for Deaf People, T0 on randomisation, T1 6 months after Arm B participant has received dog, T2 12 months after Arm B participant has received dog, T3 18 months after Arm B participant has received dog, T4 24 months after Arm B participant has received dog). Only participants who received their dog before July 2018 will be eligible to receive T3/T4 questionnaires). 1. Quality of Life measured using EQ5D 2. Anxiety measured using GAD7 3. Depression measured using PHQ9 4. Impairment in functioning using WSAS 5. Problems associated with hearing impairment which a hearing dog is meant to alleviate, measured using the Hearing Dog Questionnaire

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026