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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534387
• Other study ID #: 1R21DC018655-01
• Secondary ID: 1R21DC018655-01
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: University of South Florida
• Contact: Michelle Arnold, Au.D., Ph.D.
• Phone: 813-974-8804
• Email: mlarnold[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• Spanish-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.
• American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts
Standard of care patient education handouts developed by ASHA in the Spanish language.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Efficacy for Hearing Loss Management (disease-specific primary outcome)	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.	Assessed 4-6 weeks post baseline assessment
Primary	Self-Efficacy for Chronic Health Condition Management (generic primary outcome)	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 (a=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.	Assessed 4-6 weeks post baseline assessment
Secondary	Hearing Loss Knowledge, Attitudes, and Behaviors	Measured 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 a=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.	Assessed 4-6 weeks post baseline assessment