Intervention for Hearing Health Among Native Americans
ConditionNoise-Induced Hearing Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Younger than the age of 18
Non Native American community member
Unwillingness to provide informed consent to participate in the study
Trial design
Design model
Crossover
Treatments tested in this trial
Talking Circle
BehavioralThe TC intervention involves applying a tribal specific theory-based approach. The TCI is based within the Native Reliance theoretical model, which is a cultural identity construct that reflects the holistic worldview, values, beliefs, and behaviors within Native American culture. The community partnership community will assess and validate appropriate tribal language, community needs, and culturally content to be included in the TCI.
Diabetes prevention program & delayed TC
BehavioralThe control group participants will receive the video/audio computer program on hearing, hearing loss, and diabetes prevention strategies. Participants will receive the delayed TCI after completing the 12-month follow up.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Talking Circle InterventionExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Self-efficacy in Use of Hearing Protection
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."
Time frame
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.2
Benefits of Use of Hearing Protection
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."
Time frame
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.3
Barriers to Use of Hearing Protection
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."
Time frame
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.4
Use of Hearing Protections Devices
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.
Time frame
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
University of Texas at Austin
Collaborator
Source ClinicalTrials.gov
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