Feasibility of a trial of the ACE programme for NHS patients with hearing impairment

Not Applicable

Completed

• Conditions: Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat; UKCRC code/ Disease: Ear/ Other disorders of ear; Ear, Nose and Throat; Hearing Impairment

• Registration Number: ISRCTN28090877
• Lead Sponsor: Bradford Teaching Hospitals NHS Foundation Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-02
• Study Completion: 2019-01-31
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified