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Intervention for Hearing Health Among Native Americans

Intervention for Hearing Health Among Native Americans

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07534098
Acronym
IHHANA
Enrollment
400
Registered
2026-04-16
Start date
2027-04-01
Completion date
2030-04-30
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noise-Induced Hearing Loss

Keywords

Native American, hearing health

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.

Interventions

BEHAVIORALTalking Circle

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.

BEHAVIORALDiabetes prevention program & delayed TC

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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Texas at Austin
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

A randomized experimental pretest-posttest control group design will be used to test the effectiveness of the intervention. All participants assigned to experimental group will receive the talking circle intervention (TCI) immediately after baseline assessment and hearing test. To assess the mid-term and long-term effects of the intervention, follow-up assessments will be completed at 6-months and 12-months post-intervention with the offer of incremental increased incentives to reduce attrition. The control group will receive the delayed TCI after completing the 12-month follow up. Both groups will receive the second hearing tests at the 12-month mark and receive feedback on their hearing test results in comparison with the previous year's result.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Younger than the age of 18 * Non Native American community member * Unwillingness to provide informed consent to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Self-efficacy in Use of Hearing ProtectionData 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 ProtectionData 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 ProtectionData 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 DevicesData 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.

Countries

United States

Contacts

CONTACTOi Saeng Hong, PhD, RN, FAAN, FAAOHN
OiSaeng.Hong@ucsf.edu415-502-5581
CONTACTJohn R Lowe, RN, PHD, FAAN
john.lowe@austin.utexas.edu
PRINCIPAL_INVESTIGATOROi Saeng Hong, PhD, RN, FAAN, FAAOHN

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026