Intervention for Hearing Health Among Native Americans
IHHANA
2 other identifiers
interventional
400
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2027
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2026
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedStudy Start
First participant enrolled
April 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2029
Study Completion
Last participant's last visit for all outcomes
April 30, 2030
August 21, 2026
August 1, 2026
2 years
April 9, 2026
August 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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."
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
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."
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
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."
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
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.
Data collected at 3 time points: Baseline enrollment, 6 months, and 12 months.
Study Arms (2)
Talking Circle Intervention
EXPERIMENTALAt 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.
Control group
OTHERParticipants 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.
Interventions
The 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.
The 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Younger than the age of 18
- Non Native American community member
- Unwillingness to provide informed consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
American Indians In Texas at the Spanish Colonial Missions
San Antonio, Texas, 78205, United States
American Indians In Texas at the Spanish Colonial Missions
San Antonio, Texas, 78205, United States
Related Publications (5)
Lowe J, Liang H, Riggs C, Henson J, Elder T. Community partnership to affect substance abuse among Native American adolescents. Am J Drug Alcohol Abuse. 2012 Sep;38(5):450-5. doi: 10.3109/00952990.2012.694534.
PMID: 22931079BACKGROUNDHong O, Ronis DL, Lusk SL, Kee GS. Efficacy of a computer-based hearing test and tailored hearing protection intervention. Int J Behav Med. 2006;13(4):304-14. doi: 10.1207/s15327558ijbm1304_5.
PMID: 17228988BACKGROUNDHong O, Chin DL, Ronis DL. Predictors of hearing protection behavior among firefighters in the United States. Int J Behav Med. 2013 Mar;20(1):121-30. doi: 10.1007/s12529-011-9207-0.
PMID: 22161219BACKGROUNDHong O, Lusk SL, Ronis DL. Ethnic differences in predictors of hearing protection behavior between Black and White workers. Res Theory Nurs Pract. 2005 Spring;19(1):63-76. doi: 10.1891/rtnp.19.1.63.66339.
PMID: 15989167BACKGROUNDLowe J, Wagner E, Hospital M, et al. Utility of the Native-Reliance theoretical framework, model, and questionnaire. Journal of Cultural Diversity. 2019 26(2):61-68.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oi Saeng Hong, PhD, RN, FAAN, FAAOHN
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2026
First Posted
April 16, 2026
Study Start (Estimated)
April 1, 2027
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
April 30, 2030
Last Updated
August 21, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share