Investigating the Impact of Hearing Aid Fitting on Fatigue.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Change in Fatigue Assessment Scale (FAS)
研究概览
简要总结
An intervention group and a control group will complete a battery of questionnaires at four time points to investigate the impact of first-ever hearing aid fitting on fatigue and associated variables. The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care.
详细描述
Hearing Impairment leads to increased listening effort which could result in short and/or long term fatigue. Previous research has shown that people with a hearing loss score higher on fatigue questionnaires than people without a hearing loss. Hearing Aid fitting has been shown to reduce fatigue in an objective measurement study, however no reduction has been shown using subjective measurement. To examine the effect of hearing aid fitting on fatigue a longitudinal study will be conducted. A battery of questionnaires measuring fatigue, listening effort, daily activity, need for cognition and hearing handicap as well as an objective hearing test will be conducted at 4 time points. These time points will be a baseline assessment before hearing aid fitting, 2 weeks after fitting (~3 months after baseline), 3 months after fitting and 6 months after fitting. A control group with no change in hearing aid status will also be measured at these time points. The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care. This study monitors the effect of the hearing aid fitting.
The general hypothesis is that hearing aid fitting will reduce fatigue. More specifically it is expected that fatigue will increase immediately after fitting and then decrease by the 6 month time point. It is also expected that social activity levels will increase after fitting and that individual differences in this activity change will explain some of the differences between participants in rate of change in fatigue. It is predicted that high Need for Cognition and Hearing Handicap scores will increase the amount of change in fatigue for the intervention group. 57 participants will be recruited for each group, each participant being involved in the study for no more than 7 months with the study running for a total of 15 months. The data will be analysed using multi-level analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A self-reported hearing loss.
- •Aged between 18 and 75 years old.
- •Inclusion criteria for intervention group only:
- •Must already have an appointment arranged to receive a hearing aid for the first time.
- •Inclusion criteria for control group only:
- •No change in hearing aid status (including new models) for the past 1 year.
排除标准
- •Non fluent English speakers. (To maintain validity of results as English language questionnaires are used)
- •Inability to read (In order to complete the questionnaires).
- •Inability to visit on multiple occasions over 7 months (e.g. can't be planning to move away from the area).
- •Inability to give full informed consent.
- •Primary complaint of tinnitus.
结局指标
主要结局
Change in Fatigue Assessment Scale (FAS)
时间窗: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
A self-report measure of general fatigue.
次要结局
- Change in the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in Social activity log (SAL)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in Auditory Lifestyle Demand Questionnaire (ALDQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Craig Handicap Assessment and Reporting Technique (CHART)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in Vanderbilt Fatigue Scale (VFS)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in International Physical Activity Questionnaire short form (IPAQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in Social Participation Restrictions Questionnaire (SPaRQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Need for Cognition Scale (NFCS)(Once at baseline assessment only)
- Change in Hearing Handicap Inventory for Adults (HHIA)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in Listening Effort Assessment Questionnaire (LEAS)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
- Change in Social Participation Questionnaire (SPQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)