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Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care

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ClinicalTrials.gov Identifier: NCT03864003
Recruitment Status : Active, not recruiting
First Posted : March 6, 2019
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Laura Coco, University of Arizona

Brief Summary:
The purpose of this study is to test the feasibility of a teleaudiology intervention with assistance from Community Health Workers to improve access to hearing health care.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Participants randomized to the experimental group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a Community Health Worker.
Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care
In this project, remote hearing aid fittings will be delivered by an audiologist with patient-site support from a local facilitator for a cohort of older adults (>50 years) from a rural area that has been identified as under-resourced for hearing health care.

Active Comparator: Control Group
Participants randomized to the control group will receive hearing aid fitting and verification services via teleaudiology with local, hands-on support from a non-Community Health Worker (undergraduate student in Speech, Language, and Hearing Sciences).
Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care
In this project, remote hearing aid fittings will be delivered by an audiologist with patient-site support from a local facilitator for a cohort of older adults (>50 years) from a rural area that has been identified as under-resourced for hearing health care.




Primary Outcome Measures :
  1. Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire [ Time Frame: Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting ]

    The Self-Efficacy for Situational Communication Management Questionnaire (Jennings, 2005; Jennings et al, 2014) measures self-perceived hearing ability and hearing self-efficacy, or a participant's beliefs in their ability to manage communication with acquired hearing loss. The SESMQ contains 20 situations that are rated on two scales, hearing ability and perceived self-efficacy. Participants respond on a Likert scale from 0 (not well at all) to 10 (very well) to how well they can hear and how well they can manage in each situation. Total scores on each scale range from 0-200, with higher scores representing better perceived self-efficacy and better hearing ability. The two scales are scored and reported separately.

    We will evaluate the differences in SESMQ scores between experimental and control groups at 2-weeks post hearing aid fitting. Analyses will utilize baseline data and follow-up analyses will occur for 6-week and 12-week timepoints.



Secondary Outcome Measures :
  1. Hearing aid benefit [ Time Frame: Baseline, 6 weeks, and 14 weeks after hearing aid fitting ]

    The Effectiveness of Auditory Rehabilitation (Yueh et al., 2005; EAR) is a subjective scale of hearing aid function and quality of life. The first set of questions is administered before and after the hearing aid fitting, and relates to hearing concerns, including listening in quiet and other situations. The second set of questions relates to functioning with the hearing device, such as fit and convenience, and is administered after the hearing aid fitting.

    We will evaluate the differences in inner EAR scores between experimental and control groups at 6-weeks post hearing aid fitting. Analyses will utilize baseline data where appropriate and follow-up analyses will occur for 6-week and 12-week timepoints.

    Participants are asked to respond to statements on a five-point scale (i.e. very poor, poor, so-so, good, very good). Each answer is awarded a point. Higher cumulative scores indicate better benefit.


  2. Satisfaction with teleaudiology service delivery [ Time Frame: 2 weeks after hearing aid fitting ]

    Telehealth Satisfaction Scale (TeSS)

    The TeSS is a 10-item scale probing satisfaction with telehealth services. Responses are on a 4-point likert scale (Excellent, good, poor, fair). Higher cumulative scores represent better satisfaction.


  3. Qualitative outcomes via semi-structured interviews [ Time Frame: 14 weeks after hearing aid fitting ]
    Qualitative outcomes will target participants' subjective experience on access to hearing health care, self-efficacy, benefit, and satisfaction with service delivery and hearing aids.

  4. Average hours of hearing aid usage per day [ Time Frame: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting ]
    We will ask participants the approximate average hours per day they use their hearing aid. This information will also be collected from the hearing aid programming software.

  5. Subjective hearing aid benefit [ Time Frame: 2 weeks, 6 weeks, 14 weeks after hearing aid fitting ]
    Subjective hearing aid benefit will also be measured using a patient reported outcome measure, the International Outcome Inventory for Hearing Aids (IOI-HA). Participants are asked to respond to seven questions on their experience with their hearing aids. Questions on the IOI-HA are on a 5-point Likert-type scale. Cumulative scores range from zero to 35. Higher scores represent better benefit.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bilateral hearing loss within the fitting range of study hearing aids

Exclusion Criteria:

  • Medically unqualified to receive hearing aids
  • Current hearing aid user
  • Cognitively impaired

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864003


Locations
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United States, Arizona
Mariposa Community Health Center
Nogales, Arizona, United States, 85621
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Laura S Coco, AuD University of Arizona
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Responsible Party: Laura Coco, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT03864003    
Other Study ID Numbers: 1F32DC017081 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases