Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat
Conditions
Interventions
A remote, centralised randomisation service provided by the York Trials Unit (YTU) will allocate participants to one of two groups. Eligible, consenting patients from the same study site who have comp
listening in background noise
conversation in the home and with difficult speakers
listening to environmental sounds and
building communication confidence. Using WHO’s ICF as an underpinning framework, the programme adopts a problem solving interactive approach aimed at reducing everyday communication difficulties exper
Sponsors
Bradford Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/03/2018: 1. Adult Direct Access GP referral 2. Moderate or less than moderate self-reported hearing aid benefit, defined by IOI-HA question 2 3. Aged 18 years or over, receiving treatment-as-usual delivered in one of the two participating centres. 4. Hearing impairment: pure-tone average better ear thresholds at 500, 1000, 2000, and 4000 Hz of more than 25 dB HTL. 5. No significant self-reported history of neurological impairment 6. Willing and able to provide written informed consent 7. Able to take part in the intervention by understanding and using spoken English 8. Able to self-complete the English language outcome measure tools The following inclusion criteria for SOs will be assessed: Should be a spouse or other family member who lives with or is a carer for a patient recruited to the study. Previous inclusion criteria: 1. Adult Direct Access GP referral 2. Self-reported hearing-aid use less than three hours a day (supported by amount of use recorded by the hearing aid log if available; less than moderate benefit, defined by IOI-HA49 questions 1 and 2) 3. Aged 18 years or over, receiving treatment-as-usual delivered in one of the two participating centres. 4. Hearing impairment: pure-tone average better ear thresholds at 500, 1000, 2000, and 4000 Hz of more than 25 dB HTL. 5. No significant self-reported history of neurological impairment 6. Willing and able to provide written informed consent 7. Able to take part in the intervention by understanding and using spoken English 8. Able to self-complete the English language outcome measure tools The following inclusion criteria for SOs will be assessed: Should be a spouse or other family member who lives with or is a carer for a patient recruited to the study.
Exclusion criteria
Exclusion criteria: 1. Severe or profound bilateral hearing impairment. Pure-tone better ear average thresholds measured at 500, 1000, 2000, and 4000 Hz of more than 85 dB HTL 2. Significant on-going ear related health or mental health issues that, in the audiologist’s or associate audiologist’s professional opinion would preclude hearing-aid fitting or attendance at ACE sessions 3. Unable or unwilling to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: ACE Delivery outcomes: 1. Attendance and attrition: Attendance rates of participants and significant others at ACE sessions will be measured and who attends ACE session with the participant will be recorded 2. Fit of ACE with existing service delivery models: Attendance and attrition rates for ACE delivered at different study sites and their satellite clinics and the effect of using single and block-booking for follow-up appointments will be recorded 3. Whether ACE be delivered as intended in the ACE protocol will be assessed by recording time taken to train audiologists successfully; the number of ACE goals achieved by participants; and audiologist’s adherence to the ACE protocol (fidelity) 4. Acceptability is measured using a bespoke acceptability questionnaire/interview regarding study processes administered to participants, significant others and audiologists at final ACE session and at a comparable time for the questions for the control arm RCT Delivery Outcomes: 1. Recruitment (during 12 month recruitment following 3 month post-hearing-aid fitting follow up appointment): Number of direct referrals; number of direct referrals struggling with their hearing-aid; number of and reasons for exclusions; number of patients who decline to participate and reason for declining; number who miss ACE intervention window (i.e. unable to attend an ACE group within 1-3 weeks after randomisation); number given an appointment for an ACE group session; and number of consented patients who fail to attend ACE 2. Allocation: Time ACE started after randomisation (ACE intervention window); time taken to recruit and logistics of recruiting an optimally sized and located ACE group 3. Outcome Measure Data: Completion and return rates of outcome measures at each time-point will be recorded as well as extent of missing data | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hearing aid benefit is measured in control and intervention arms at 3 and 6 months post hearing aid fitting using the International Outcomes Inventory for Hearing Aids (IOI-HA) 2. ACE benefit is measured in the intervention arm only, at the end of the ACE intervention and 6 months post hearing aid fitting using the International Outcomes Inventory for Alternative Interventions (IOI-AI) 3. Communication benefit is measured in control and intervention arms at 3 and 6 months post hearing aid fitting using Self-Assessment of Communication (SAC) 4. Quality of Life is measured in control and intervention arms using the EQ-5D-5 and Short-Form 36 (SF-36) at 3 and 6 months post hearing aid fitting 5. Significant Others’ benefit from the ACE intervention is measured in the intervention arm only, using the International Outcome Inventory for Alternative Interventions: version for Significant Others (IOI-AI-SO) at the end of the ACE intervention and 6 months post hearing aid fitting 6. Hearing disability associated with significant others is measured in control and intervention arms at 3 and 6 months post hearing aid fitting using the Significant Other Scale for Hearing Disability (SOS-HEAR) | — |
Countries
England, United Kingdom
Outcome results
None listed