The Feasibility of mHealth Technologies to Improve Hearing Aid Use and Benefit in First-time Hearing Aid Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999) - Hearing aid use
研究概览
简要总结
This study will establish the feasibility of a theoretically-driven, personalised educational intervention delivered through mobile technologies in first-time hearing aid users. Namely, the C2Hear (https://www.youtube.com/C2HearOnline) multimedia videos, or Reusable Learning Objects (RLOs) (Ferguson et al., 2015; 2016), will be repurposed into short 'bite-sized' mobile-enabled RLOs (mRLOs).The development of the intervention will be based on a recently developed comprehensive model of health behaviour change (COM-B) (Michie et al., 2014). The intervention will be tailored to individuals' needs, and incorporate greater user interactivity and self-evaluation.
详细描述
Research question: Is it feasible for first-time hearing aid users to use a personalised educational intervention delivered through mobile technologies in their everyday life?
Objectives: To establish the feasibility of the intervention by evaluating delivery, accessibility, usability, acceptability, and adherence in first-time hearing aid users. To establish suitable outcome measures to evaluate the effectiveness of the intervention in a future randomised controlled trial.
Study Design: Single centre, feasibility.
Naïve first-time hearing aid users will try out the intervention away from the laboratory. Following 10-12 weeks of independent use, the investigators will assess how the participants used the intervention using a mixed-methods approach across two parallel stages:
Stage 1. The investigators will assess the feasibility of the intervention in first-time hearing aid users, who will be invited to take part in semi-structured interviews. Using the COM-B model (Michie et al., 2014) as the framework underpinning the interviews, delivery, accessibility, usability, acceptability, and adherence of the intervention will be evaluated. Transcribed audio-recordings will be analysed using thematic analysis (Braun & Clarke, 2006). A total of 15 participants is typically sufficient to achieve data saturation (the point in data collection when no new information emerges) using this qualitative methodology (Guest et al., 2006). To allow for 18% attrition (Ferguson et al., 2016), 18 patients will be. To prevent potential confounding of the interviews, participants will not be required to complete quantitative outcome measures used in stage 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •First-time hearing aid users (or if previous users, but not having worn hearing aids for more than 3 years)
- •Familiar with mobile technologies (e.g. owns a smartphone or tablet device, or uses one regularly)
- •English as a first spoken language or a good understanding of English. It is important that participants can understand the content of the resources and work with the interactive elements, as well as be able to answer outcome questionnaires, to ensure valid data are collected.
排除标准
- •Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.
结局指标
主要结局
Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999) - Hearing aid use
时间窗: Following 10-12 weeks of independent use of the mRLO intervention
Self-reported hearing aid use measured on a five-point scale.
次要结局
- Glasgow Hearing Aid Benefit Profile (GHABP)(Baseline (Part I) and following 10-12 weeks of independent use of the mRLO intervention (Part II))
- Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)(Baseline and following 10-12 weeks of independent use of the mRLO intervention)
- Hearing aid datalogging(Following 10-12 weeks of independent use of the mRLO intervention)
- Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2015)(Baseline and following 10-12 weeks of independent use of the mRLO intervention)
- Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA: West & Smith, 2007)(Baseline and following 10-12 weeks of independent use of the mRLO intervention)
- Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)(Baseline and following 10-12 weeks of independent use of the mRLO intervention)
- Clinical Global Impression Scale - Hearing difficulties(Baseline and following 10-12 weeks of independent use of the mRLO intervention)
- Wechsler Adult Intelligence Scale (WAIS) - Digit Span (Wechsler, 1997)(Baseline and following 10-12 weeks of independent use of the mRLO intervention)