Assessing the Feasibility of a Clinical Trial of an Online Audiological Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)
研究概览
简要总结
The study will assess the feasibility of conducting a full-scale clinical trial of the effectiveness of an online rehabilitation program for adults living with hearing loss. The program aims to help people use their hearing aid(s) and interact in social settings more effectively. The program is made up of 5 modules that cover different topics, such as hearing aids, communication strategies, and relaxation techniques.
详细描述
STUDY PURPOSE
This feasibility study is a precursor of a randomised controlled trial (RCT) that will evaluate the effectiveness of an English-speaking version of the online program originally evaluated by Thorén et al in adult hearing aid users. This study will estimate a number of parameters necessary for the robust design of an RCT. This systematic approach of completing a feasibility study prior to a full-scale evaluation is strongly advocated by the Medical Research Council (MRC) guidelines for developing and evaluating complex interventions, ensuring that any uncertainties are addressed and that the intervention operates as intended.
OBJECTIVES
This study will be used to estimate the following parameters:
(I) Recruitment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •English as first spoken language or good understanding of English.
- •Adults aged ≥18 years (no upper age limit)
- •Mild-to-moderate hearing loss (average hearing threshold across octave frequencies 0.25-4kHz ≥20 and ≤70dB HL)
- •Have either:
- •Used hearing aids for at least one year (existing hearing aid users), or
- •Have not used hearing aids or an alternative form of amplification (e.g. personal sound amplification products) within the past two years (first-time hearing aid users)
- •Access the Internet and compatible device (e.g. computer or tablet device).
排除标准
- •Report having severe tinnitus
- •Diagnosis of Ménière's disease
- •Patients who are unable to complete the questionnaires without assistance due to age- related problems such as cognitive decline and dementia.
研究组 & 干预措施
Eriksholm Guide to Better Hearing
The Eriksholm Guide to Better Hearing is an online rehabilitation program. The program is made up of 5-weekly modules that cover different topics. Each module includes self-studies, training, and professional video coaching in hearing loss, hearing aids, and communication strategies.
干预措施: Eriksholm Guide to Better Hearing (Other)
结局指标
主要结局
Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)
时间窗: Change from Baseline following up to 5 weeks of independent use of the online intervention
A 25-item questionnaire designed to assess the effects of hearing loss on the emotional (n = 13), and social/situational adjustment (n = 12) of older people, scored using a three-point scale (4 = yes; 2 = sometimes; 0 = no).
次要结局
- Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999)(Baseline (Part 1 only) and following up to 5 weeks of independent use of the online intervention (Part 2 only))
- Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA: West & Smith, 2007)(Baseline and following up to 5 weeks of independent use of the online intervention)
- International Outcome Inventory for Hearing Aids (IOI-HA: Cox & Alexander, 2002)(Baseline and following up to 5 weeks of independent use of the online intervention)
- Practical Hearing Aid Skills Test (PHAST: Desjardins & Doherty, 2009)(Baseline and following up to 5 weeks of independent use of the online intervention)
- Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2016)(Baseline and following up to 5 weeks of independent use of the online intervention)
- Hearing Aid and Communication Knowledge (HACK: Ferguson et al, 2015)(Baseline and following up to 5 weeks of independent use of the online intervention)