Clinical trial NCT04534387: Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
Official title: Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2020-09-01
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Efficacy for Hearing Loss Management (disease-specific primary outcome)
timeFrame: Assessed 4-6 weeks post baseline assessment
measure: Self-Efficacy for Chronic Health Condition Management (generic primary outcome)
timeFrame: Assessed 4-6 weeks post baseline assessment
Secondary outcomes:
measure: Hearing Loss Knowledge, Attitudes, and Behaviors
timeFrame: Assessed 4-6 weeks post baseline assessment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Michelle Arnold, Au.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Victoria Sanchez, Au.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: