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Clinical Trials/NCT04534387
NCT04534387RecruitingNot Applicable

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

University of South Florida1 site in 1 country110 target enrollmentStarted: April 22, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
110
Locations
1
Primary Endpoint
Self-Efficacy for Chronic Health Condition Management (generic primary outcome)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Experimental Group

Experimental

This group will receive the Spanish-Language Hearing Loss Toolkit materials.

Intervention: Spanish-Language Hearing Loss Toolkit for Self-Management (Other)

Active Control Group

Active Comparator

This group will receive standard of care Spanish language information from the American Speech-Language-Hearing Association (ASHA) Audiology Series

Intervention: American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts (Other)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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