ISRCTN28090877已完成未知
Feasibility of a randomised controlled trial of the Active Communication Education (ACE) programme plus hearing-aid provision versus hearing-aid provision alone
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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