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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Behavioral: Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Nogales, Arizona, United States, 85621
      • Mariposa Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire	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.	Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing aid benefit	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.	Baseline, 6 weeks, and 14 weeks after hearing aid fitting
Satisfaction with teleaudiology service delivery	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.	2 weeks after hearing aid fitting
Qualitative outcomes via semi-structured interviews	Qualitative outcomes will target participants' subjective experience on access to hearing health care, self-efficacy, benefit, and satisfaction with service delivery and hearing aids.	14 weeks after hearing aid fitting
Average hours of hearing aid usage per day	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.	2 weeks, 6 weeks, 14 weeks after hearing aid fitting
Subjective hearing aid benefit	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.	2 weeks, 6 weeks, 14 weeks after hearing aid fitting

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Laura S Coco, AuD, University of Arizona

Publications and helpful links

General Publications

• Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: March 3, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 1F32DC017081 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No