Feasibility of a randomised controlled trial of the Active Communication Education (ACE) programme plus hearing-aid provision versus hearing-aid provision alone

Overview

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30068614 protocol (added 18/10/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33827834/ (added 09/04/2021)

Registry

who.int

Start Date

March 2, 2017

End Date

January 31, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•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:

•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