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Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management

Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04534387
Enrollment
110
Registered
2020-09-01
Start date
2021-04-22
Completion date
2024-03-30
Last updated
2023-05-09

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

Conditions

Hearing Loss

Brief summary

The objective of this application is to develop and evaluate Spanish-language hearing education materials for adults. Our hypothesis is that participants will demonstrate better understanding of their hearing loss and associated difficulties, and will be better able to identify options for self-management following delivery of culturally and linguistically appropriate patient education materials.

Detailed description

There are documented disparities in hearing healthcare use between Hispanic/Latino adults and non-Hispanic/Latino Whites, despite similar hearing loss prevalence rates. It has been suggested that a lack of culturally competent interventions contributes to poor healthcare delivery and outcomes for those with limited English proficiency. The objective of this application is to develop and evaluate Spanish-language hearing education materials for adults. Our hypothesis is that participants will demonstrate better understanding of their hearing loss and associated difficulties, and will be better able to identify options for self-management following delivery of culturally and linguistically appropriate patient education materials. The rationale for the proposed research is that findings will contribute to the development and testing of novel interventions aimed at increasing hearing healthcare access and utilization in vulnerable populations in a subsequent R01 application.

Interventions

OTHERSpanish-Language Hearing Loss Toolkit for Self-Management

The materials include printed information and images designed to increase hearing loss knowledge and focus on self-management topics such as the fundamentals of the ear and hearing, communication strategies, speech understanding in noise, and hearing technology.

OTHERAmerican Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts

Standard of care patient education handouts developed by ASHA in the Spanish language.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of South Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

1. Participants will include community-dwelling, Spanish-speaking (monolingual or bilingual) adults over age 50 who self-identify as Hispanic/Latino 2. Clinically-significant hearing loss defined as either greater than 25 decibels hearing leve (dB HL) thresholds at 2 or more frequencies from 250 - 8000 hertz (Hz) and/or significant self-reported hearing difficulties as defined by a score of greater than 8 on the Hearing Handicap Inventory - Screening measure for adults/elderly.

Exclusion criteria

* Individuals who are not fluent Spanish-speakers or who do not self-identify as Hispanic/Latino are not eligible to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
Self-Efficacy for Hearing Loss Management (disease-specific primary outcome)Assessed 4-6 weeks post baseline assessmentMeasured by the Partners in Health Scale-Audiology version. The original Partners in Health scale assesses management of chronic conditions and has been validated in several languages, including Spanish. Items are scored from 0-8 with higher scores indicating better self-management. The Partners in Health Scale-Audiology is an 11-item modified version of the original Partners in Health scale, and assesses the hearing loss-specific domains of actions, psychosocial behaviors, and knowledge.
Self-Efficacy for Chronic Health Condition Management (generic primary outcome)Assessed 4-6 weeks post baseline assessmentMeasured by the Self-Efficacy to Mange Chronic Disease Scale-Spanish language version. The Self-Efficacy to Mange Chronic Disease Scale is a 4-item scale with high internal consistency (α=0.93) that measures changes in self-efficacy following participation in a disease self-management program. Items are scored from 1-10 with higher scores indicating better condition self-management.

Secondary

MeasureTime frameDescription
Hearing Loss Knowledge, Attitudes, and BehaviorsAssessed 4-6 weeks post baseline assessmentMeasured using the Hearing Beliefs Questionnaire. Assesses participants' knowledge, attitudes, and behaviors related to hearing loss at baseline and post-intervention. The Hearing Beliefs Questionnaire is a 26-item measure segmented into 6 domains: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, perceived self-efficacy, and cues to action. Each domain includes between 3 and 8 visual analog scale items, with a range of adequate internal consistency of α=0.61-0.77. Possible score range for each item is 0 to 10, ranging from two endpoints of highly agree to highly disagree and highly likely to highly unlikely. Item responses are averaged across domains as summary scores. As a Spanish-language version has not yet been validated, the Hearing Beliefs Questionnaire will be included as a secondary, exploratory outcome.

Countries

United States

Contacts

Primary ContactMichelle Arnold, Au.D., Ph.D.
mlarnold@usf.edu813-974-8804
Backup ContactVictoria Sanchez, Au.D., Ph.D.
vasanchez@usf.edu813-414-3491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026