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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DC018655-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | This group will receive the Spanish-Language Hearing Loss Toolkit materials. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spanish-Language Hearing Loss Toolkit for Self-Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Arnold, Au.D., Ph.D. | Contact | 813-974-8804 | mlarnold@usf.edu | |
| Victoria Sanchez, Au.D., Ph.D. | Contact | 813-414-3491 | vasanchez@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Arnold, Au.D., Ph.D. | University of South Florida | Principal Investigator |
| Victoria Sanchez, Au.D., Ph.D. | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33620 | United States |
IPD will be shared upon request.
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).
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2021 | Mar 24, 2022 |
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| American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts | Other | Standard of care patient education handouts developed by ASHA in the Spanish language. |
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| Assessed 4-6 weeks post baseline assessment |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| D016235 | American Speech-Language-Hearing Association |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012952 | Societies |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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