Intervention for Hearing Health Among Native Americans

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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Talking Circle InterventionExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Knowledge of Noise-Induced Hearing Loss

Knowledge of NIHL will be assessed by benefits and barriers (3-item and 6-item, 5-point Likert scales, respectively) of Use of Hearing Protection as reflecting declarative knowledge (factual), and self-efficacy (2-item, 5-point Likert scale) in Use of Hearing Protection as reflecting procedure knowledge (how to do).

Time frame
Data collected at 3 time points: baseline enrollment, and at 6 and 12-month posttests.
2

Use of Hearing Protections Devices (HPDs)

Mean use of HPDs will be calculated using the participant's use of HPDs in percentage of the time (0%-100%) when in loud noise at two time points (the past three months and one month) measured at pretest and at 6 and 12-month posttests. 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 baseline enrollment and at 6 and 12-month posttests.

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

University of Texas at Austin

Collaborator

This trial is not recruiting at the moment. You can still explore other options: