Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spanish-Language Hearing Loss Toolkit for Self-Management
American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
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.
Sites / Locations
- University of South FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Active Control Group
Arm Description
This group will receive the Spanish-Language Hearing Loss Toolkit materials.
This group will receive standard of care Spanish language information from the American Speech-Language-Hearing Association (ASHA) Audiology Series
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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 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.
Full Information
NCT ID
NCT04534387
First Posted
August 26, 2020
Last Updated
May 8, 2023
Sponsor
University of South Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT04534387
Brief Title
Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
Official Title
Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
This group will receive the Spanish-Language Hearing Loss Toolkit materials.
Arm Title
Active Control Group
Arm Type
Active Comparator
Arm Description
This group will receive standard of care Spanish language information from the American Speech-Language-Hearing Association (ASHA) Audiology Series
Intervention Type
Other
Intervention Name(s)
Spanish-Language Hearing Loss Toolkit for Self-Management
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts
Intervention Description
Standard of care patient education handouts developed by ASHA in the Spanish language.
Primary Outcome Measure Information:
Title
Self-Efficacy for Hearing Loss Management (disease-specific primary outcome)
Description
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.
Time Frame
Assessed 4-6 weeks post baseline assessment
Title
Self-Efficacy for Chronic Health Condition Management (generic primary outcome)
Description
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.
Time Frame
Assessed 4-6 weeks post baseline assessment
Secondary Outcome Measure Information:
Title
Hearing Loss Knowledge, Attitudes, and Behaviors
Description
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.
Time Frame
Assessed 4-6 weeks post baseline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Arnold, Au.D., Ph.D.
Phone
813-974-8804
Email
mlarnold@usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Sanchez, Au.D., Ph.D.
Phone
813-414-3491
Email
vasanchez@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Arnold, Au.D., Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Sanchez, Au.D., Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Arnold, PhD
Phone
813-974-1262
Email
mlarnold@usf.edu
First Name & Middle Initial & Last Name & Degree
Victoria Sanchez, PhD
Phone
8139721262
Email
vasanchez@usf.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared upon request.
IPD Sharing 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).
IPD Sharing 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.
Learn more about this trial
Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management
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