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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mariposa Community Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 3, 2019
Last Updated
May 15, 2022
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03864003
Brief Title
Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
Official Title
Community Health Workers and Teleaudiology as a Culturally-relevant Approach to Improving Access to Hearing Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

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 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.

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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care
Intervention Description
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 Measure Information:
Title
Self-efficacy: The Self-Efficacy for Situational Communication Management Questionnaire
Description
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.
Time Frame
Baseline, 2 weeks, 6 weeks, and 12 weeks after hearing aid fitting
Secondary Outcome Measure Information:
Title
Hearing aid benefit
Description
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.
Time Frame
Baseline, 6 weeks, and 14 weeks after hearing aid fitting
Title
Satisfaction with teleaudiology service delivery
Description
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.
Time Frame
2 weeks after hearing aid fitting
Title
Qualitative outcomes via semi-structured interviews
Description
Qualitative outcomes will target participants' subjective experience on access to hearing health care, self-efficacy, benefit, and satisfaction with service delivery and hearing aids.
Time Frame
14 weeks after hearing aid fitting
Title
Average hours of hearing aid usage per day
Description
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.
Time Frame
2 weeks, 6 weeks, 14 weeks after hearing aid fitting
Title
Subjective hearing aid benefit
Description
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.
Time Frame
2 weeks, 6 weeks, 14 weeks after hearing aid fitting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura S Coco, AuD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mariposa Community Health Center
City
Nogales
State/Province
Arizona
ZIP/Postal Code
85621
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35724253
Citation
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.
Results Reference
derived

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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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