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Not yet recruiting NCT07534098

Intervention for Hearing Health Among Native Americans

No phase Interventional Noise-Induced Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Talking Circle, Diabetes prevention program & delayed TC.
Who it may be relevant to
Registry conditions: Noise-Induced Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Talking 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.
  • Behavioral Diabetes 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.

Primary outcome measures

  • Knowledge of Noise-Induced Hearing Loss [Time frame: Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests.]
  • Use of Hearing Protections Devices (HPDs) [Time frame: Data collected at baseline enrollment and at 6 and 12-month posttests.]

Eligibility criteria

Inclusion criteria

  • Native American tribal member; are age 18 years and older; may work in a noisy environment; and are willing to give informed consent to participate in the study. The study will include people without hearing loss and with hearing loss as well.

Exclusion criteria

  • Younger than the age of 18, non Native American tribal member and unwillingness to give informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • United Keetoowah Band of Cherokee Indians — Tahlequah

Publications

  • 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 22931079
  • Hong 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 17228988
  • Hong 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 22161219
  • Hong 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 15989167
  • Lowe 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.

Identifiers

NCT: NCT07534098 · 24-42381 · 1R01NR021182-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗