Intervention for Hearing Health Among Native Americans

Part of paid clinical trials in Tahlequah, Oklahoma.

Sponsor
University of California, San Francisco
Study ID
NCT07534098
Status
Not Yet Recruiting

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Conditions

  • Noise-Induced Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Talking Circle — BEHAVIORAL
    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.
  • Diabetes prevention program & delayed TC — BEHAVIORAL
    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.

Study Details

The purpose of the study is to understand the cultural impact on hearing loss among Native Americans 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.

Key Dates

Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Talking Circle Intervention
    Participants randomized to the experimental group will be clustered together geographically. This design will assist to minimize contamination. At baseline, the participants will complete assessment surveys and hearing tests in their tribal district community centers. All participants assigned to experimental group will receive the TCI immediately after baseline assessment and hearing test. Each TCI group includes 10 participants who will receive TCI together at a time and day that works the best.
  • Other: 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.

Primary Outcome Measure

Knowledge of Noise-Induced Hearing Loss [ Time Frame: Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
United Keetoowah Band of Cherokee IndiansTahlequahOklahoma74464-

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United Keetoowah Band of Cherokee Indians· Tahlequah, OK

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