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Clinical Trials/NCT04534387
NCT04534387
Recruiting
N/A

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

University of South Florida1 site in 1 country110 target enrollmentApril 22, 2021
ConditionsHearing Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
University of South Florida
Enrollment
110
Locations
1
Primary Endpoint
Self-Efficacy for Chronic Health Condition Management (generic primary outcome)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2021
End Date
March 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants will include community-dwelling, Spanish-speaking (monolingual or bilingual) adults over age 50 who self-identify as Hispanic/Latino
  • 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.

Outcomes

Primary Outcomes

Self-Efficacy for Chronic Health Condition Management (generic primary outcome)

Time Frame: Assessed 4-6 weeks post baseline assessment

Measured 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.

Self-Efficacy for Hearing Loss Management (disease-specific primary outcome)

Time Frame: Assessed 4-6 weeks post baseline assessment

Measured 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.

Secondary Outcomes

  • Hearing Loss Knowledge, Attitudes, and Behaviors(Assessed 4-6 weeks post baseline assessment)

Study Sites (1)

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