Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes With Over-the-Counter Hearing Aids: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Hearing Aid Self-Efficacy
研究概览
简要总结
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.
The main questions it aims to answer are:
- Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids?
- Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.
Participants will:
- Visit for one appointment to complete a few questionnaires without OTC hearing aids
- Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences
- Visit for a second appointment to complete the same questionnaires with OTC hearing aids.
详细描述
The proposed study will use a single-arm pre-post intervention research design to achieve both the aims. Participants will complete two appointments. Assessments in the first appointment will serve as the baseline (unaided). This will be followed by a week of OTC HA use and SEBAR implementation in their natural listening situations and the outcome measures will be completed again in appointment 2 (aided) to reflect the impact of wearing OTC HAs. Scores on the outcome measures will be compared between the unaided and the aided conditions to answer both the aims. Both the appointments in the proposed study will be completed in the shared and dedicated research spaces in the Department of Audiology and Speech Pathology, College of Health Professions at the University of Arkansas for Medical Sciences. The research proposal will be submitted for the university's Institutional Review Board's approval Upon arrival participants will complete the consent process in which the PI will describe in detail all study procedures, risks and benefits of the study, and the lack of negative consequences should the participant choose to withdraw from the study or cease participation during data collection. Once the consent form has been signed, the participant will complete two appointments.
Appointment 1: For each interested participant, a standard audiometric procedure will be completed to confirm their eligibility. Once the eligible participants consent, preliminary measures will be completed. Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy, willingness to adopt HAs, expected HA satisfaction, current emotional state, and quality of life. At this time, OTC HAs will be fitted to the participants and they will receive the SEBAR. Participants will be instructed to use the HAs for at least 4 hours every day for the next week. Finally, the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher.
Appointment 2: At this appointment, data from the EMA app during the one-week field trial will be stored. HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants' preferred settings. All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 - 85 years old
- •Non-fluctuating, adult-onset, bilateral mild-to-moderate sensorineural hearing loss (average hearing thresholds for 500-3000Hz between 25- and 60-dB HL and no more than 10 dB difference between ears).
- •No previous experience with hearing aids
- •English as their first language with good self-reported health
排除标准
- •Any reported history of outer or middle ear pathologies • No participants will be excluded based on their gender, race/ethnicity.
研究组 & 干预措施
Pre-post single arm design
Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids.
干预措施: hearing aids (Device)
结局指标
主要结局
Hearing Aid Self-Efficacy
时间窗: 1 week
Measured in unaided and aided condition
Percentage of Total Confidence
时间窗: 1 week
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA), referred to as MARSHA, is a 24-item, validated, self-report questionnaire used to assess an individual's confidence (self-efficacy) in their ability to use and manage hearing aids. Participants rated their confidence for each item (0 - 100%) and the average percentage across all items was calculated as the percentage of total confidence. Scores between pre- and post-conditions were compared and reported here.
次要结局
- Hearing-related Quality of Life(1 week)
- hearing aid satisfaction(1 week)
- Willingness to adopt hearing aids(1 week)
- emotional state(1 week)
- Total Readiness Score on the URICA Scale(1 week)
- Hearing Aid Satisfaction on SADL Average Score(1 week)
- Emotional State Total Score(1 week)
- Hearing-related Quality of Life Total Score(1 week)
