Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedStudy Start
First participant enrolled
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMay 9, 2023
May 1, 2023
2.9 years
August 26, 2020
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 (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.
Assessed 4-6 weeks post baseline assessment
Secondary Outcomes (1)
Hearing Loss Knowledge, Attitudes, and Behaviors
Assessed 4-6 weeks post baseline assessment
Study Arms (2)
Experimental Group
EXPERIMENTALThis group will receive the Spanish-Language Hearing Loss Toolkit materials.
Active Control Group
ACTIVE COMPARATORThis group will receive standard of care Spanish language information from the American Speech-Language-Hearing Association (ASHA) Audiology Series
Interventions
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.
Standard of care patient education handouts developed by ASHA in the Spanish language.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Individuals who are not fluent Spanish-speakers or who do not self-identify as Hispanic/Latino are not eligible to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Florida
Tampa, Florida, 33620, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Arnold, Au.D., Ph.D.
University of South Florida
- PRINCIPAL INVESTIGATOR
Victoria Sanchez, Au.D., Ph.D.
University of South Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 1, 2020
Study Start
April 22, 2021
Primary Completion
March 30, 2024
Study Completion
March 30, 2024
Last Updated
May 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will become available upon the close of the study (March 30, 2023) and will remain available for 1 year post study-closure (March 30, 2024).
- Access Criteria
- Individuals requesting access must meet qualifications for Institution and Investigator detailed in the National Institute on Deafness and Other Communication Disorders (NIDCD) Funding Opportunity Announcement Number described in PAR-18-487.
IPD will be shared upon request.