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About the COACH trial

Do you care for adults with moderate to severe, severe, or profound hearing loss in the UK? If so, the COACH trial needs you!

NICE guidance TA566 (2019) expanded access to cochlear implantation for adults in 2019. However, there remains concern that adults without access to cochlear implants can still struggle with acoustic hearing aids. There is not enough evidence to know whether acoustic hearing aids or cochlear implants would be better for adults who fall just outside TA566. COACH aims to generate such evidence.

We are open now and actively recruiting. COACH is a unique opportunity to produce evidence to support NICE guidance change if needed, and influence cochlear implant candidacy guidance internationally.

 

Who can give out information about the COACH trial?

Any audiologist, ENT surgeon, or other professional involved with hearing care can give their hearing aid users information about the COACH trial. You would not be expected to have in-depth discussions about the trial, as these should only be had with a trained member of staff at a COACH recruiting site or member of the Nottingham Clinical Trials Unit. You can explain to potential participants that if they complete an expression of interest form, their in-depth questions will be answered by experts in the trial.

 

Which hearing aid users are we looking for?

We are looking for adults with moderate-to-severe, severe, or profound sensorineural hearing loss using one or two acoustic hearing aids. They may or may not have been referred for cochlear implant eligibility assessment in the past.

Please publicise COACH to people with these characteristics:

  • 18 years of age or older, there is no upper age limit
  • Post-lingual acquired or progressive hearing loss
  • Well-fitted acoustic hearing aid(s), unilateral or bilateral fitting
  • Sensorineural hearing loss
  • At least two unaided thresholds at ≥70 dB HL including 0.5, 1, 2, 3, or 4 kHz in both ears on standard pure tone audiometry
  • Symmetric or asymmetric hearing loss
  • Good spoken and written English language skills
  • Ability to give informed consent

 COACH infographic v3 (2)

Ways you can help

Your NHS Trust could become a COACH participant identification centre (PIC), meaning it would be reimbursed for your time spent looking for potential participants. If a PIC site uses Auditbase, we provide a custom Crystal report, and training on how to use this, to help identify adults with the correct pure tone audiometry results.

However, your department does not need to be a PIC site to promote the COACH Trial. Here are other ways you can help:

  1. Promote COACH to all the patients you see who meet the criteria we are looking for as listed above
  2. Raise awareness of the trial within your department with any audiologists who see adults using acoustic hearing aids, especially adults with severe to profound hearing loss
  3. Display posters and leave leaflets for COACH out in your waiting areas
  4. Request training from us for your audiologists to help them identify potential COACH participants
  5. Liaise with your CI Champion to ensure they are aware of their ability to recommend people to the COACH trial
  6. Discuss the contents of this webpage at your team meetings and review regularly to see if potential participants are being identified

Remember, you are not committing your patients to anything by promoting COACH, just providing them with an opportunity to find out more.

 

How do I refer someone to the COACH trial?

Options include:

  • Scan the trial QR code onto their mobile phone
  • Direct them to the home page of this website: www.coachtrial.ac.uk
  • Give them a leaflet for the COACH trial

Then they can read all the information, watch the videos, and complete an expression of interest form via the website if they are interested to find out more.

They are not committed to going any further in the trial just by completing the expression of interest form.

 

What would happen to the participant next?

Once they have completed an expression of interest form, they will be approached by their preferred recruitment site who will carry out pre-screening. If they pass pre-screening, they will be offered a consent visit to make sure they understand the trial and meet our other eligibility criteria.

Eligible adults would then be able to choose whether to proceed further in the trial.

 

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In Partnership with

This study/project is sponsored by the University of Nottingham and co-ordinated by Nottingham Clinical Trials Unit.

COACH is an NIHR portfolio adopted, registered clinical trial, sponsored by the University of Nottingham. ISRCTN 15352106. IRAS project ID 297574.