Intervention for Hearing Health Among Native Americans
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Knowledge of Noise-Induced Hearing Loss
研究概览
简要总结
The purpose of the study is to understand the cultural impact on hearing loss among Native American populations who traditionally rely on oral communication. This Native American community based participatory research hearing protection study proposes to implement a culturally relevant Talking Circles intervention to address hearing health inequities among Native Americans. The goal is to establish a sustainable culturally based Talking Circle (TC) hearing loss prevention program to disseminate messages, thus promote hearing health and improve access to preventive tools within the larger tribal community with high occupational and recreational noise exposure.
TC Participants will:
- Complete a set of questionnaires (3 total) throughout the study.
- Complete an audiometer hearing test with headphones, and watch one video computer related to hearing and how to protect hearing at the tribal wellness center.
- In 6-months into the trial, participants will be asked to complete the same set of questionnaires from the beginning of the study.
- In 12-months after the baseline surveys and hearing test, participants will be asked to complete the same set of questionnaires that were done at the beginning of the study and complete another hearing test by the computer.
The intervention will include facilitator training for local implementation and a delayed-intervention control to assess knowledge gains and protective behavior changes. Through use of the TC, the participants in the training program can use the support and insight from each other to be trained to establish self-sustaining hearing loss prevention program in the tribal community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indigenous or Native American community member
- •Age 18 years and older
- •May work in a noisy environment
- •Willing to give informed consent to participate in the study
- •People without hearing loss and with hearing loss as well
排除标准
- •Younger than the age of 18
- •Non Native American community member
- •Unwillingness to provide informed consent to participate in the study
研究组 & 干预措施
Talking Circle Intervention
At baseline, all the participants will complete assessment surveys and hearing tests in their designated community centers. All participants randomized to the experimental group will receive the TCI immediately after baseline assessment as well as the hearing test and computer-based intervention. Each TCI group includes 10 participants who will receive TCI together at a time and day that works the best.
干预措施: Talking Circle (Behavioral)
Control group
Participants randomized to the control group will receive the delayed TCI after completing the 12-month follow up. Partcipants will receive the second hearing tests 12-months into the study and receive feedback on their hearing test results in comparison with the previous year's result. The control group will be asked to randomly participate in a focus group at the completion of the study.
干预措施: Diabetes prevention program & delayed TC (Behavioral)
结局指标
主要结局
Knowledge of Noise-Induced Hearing Loss
时间窗: Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests.
Knowledge of NIHL will be assessed by benefits and barriers (3-item and 6-item, 5-point Likert scales, respectively) of Use of Hearing Protection as reflecting declarative knowledge (factual), and self-efficacy (2-item, 5-point Likert scale) in Use of Hearing Protection as reflecting procedure knowledge (how to do).
Use of Hearing Protections Devices (HPDs)
时间窗: Data collected at baseline enrollment and at 6 and 12-month posttests.
Mean use of HPDs will be calculated using the participant's use of HPDs in percentage of the time (0%-100%) when in loud noise at two time points (the past three months and one month) measured at pretest and at 6 and 12-month posttests. As the two scores for the two time points are expected to show a strong correlation, the mean of two scores will be used as the outcome variable.
Self-efficacy in Use of Hearing Protection
时间窗: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Participants' confidence in their ability to use hearing protection devices correctly will be assessed using a 2-item scale, rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors, including self-efficacy as reflecting procedure knowledge (how to do), that serve as mediators of the use of hearing protection. An example of an item from this scale is, "I am sure I can use my hearing protection, so it works effectively."
Benefits of Use of Hearing Protection
时间窗: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Participants' beliefs regarding the positive results of using hearing protection devices will be assessed by using a 3-item scale, which is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors that serve as mediators of the use of hearing protection. One of these factors includes the benefits of use as one of two components reflecting declarative knowledge (factual). A sample item for this scale is "Wearing hearing protection protects me against hearing loss from noise exposure."
Barriers to Use of Hearing Protection
时间窗: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Participants' beliefs about the potential negative aspects of hearing protection device use (i.e., inconvenience, discomfort, difficulty using hearing protection devices, and interference with communication) will be assessed using a 6-item scale, which is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Outcome (Knowledge of noise-induced hearing loss) will be assessed by 3 factors that serve as mediators of the use of hearing protection. One of these factors includes the barriers to use as one of two components reflecting declarative knowledge (factual). A sample item for his scale is, 'Hearing protection keeps me from hearing what I want to hear."
Use of Hearing Protections Devices
时间窗: Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
This 2-item scale will measure participants' frequency of hearing protection device use when exposed to high noise level at two time points (the past three months and one month), with data collected at baseline and at 6 and 12-month posttests. A sample item is " What percent of the time (0-100%) did you actually use ear plugs or muffs in the past three months when you were exposed to loud noise?" As the two scores for the two time points are expected to show a strong correlation, the mean of two scores will be used as the outcome variable.
次要结局
未报告次要终点