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

Sponsor
University of South Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04534387
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
110
1
2
23.2
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Spanish-Language Hearing Loss Toolkit for Self-Management
  • Other: American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts
N/A

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
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
Actual Study Start Date :
Apr 22, 2021
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

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

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.

Active Comparator: Active Control Group

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

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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Hearing Loss Knowledge, Attitudes, and Behaviors [Assessed 4-6 weeks post baseline assessment]

    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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Florida Tampa Florida United States 33620

Sponsors and Collaborators

  • University of South Florida
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Michelle Arnold, Au.D., Ph.D., University of South Florida
  • Principal Investigator: Victoria Sanchez, Au.D., Ph.D., University of South Florida

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of South Florida
ClinicalTrials.gov Identifier:
NCT04534387
Other Study ID Numbers:
  • 1R21DC018655-01
  • 1R21DC018655-01
First Posted:
Sep 1, 2020
Last Update Posted:
Apr 7, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022