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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864003
• Other study ID #: 1F32DC017081
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: June 4, 2020

Study information

• Verified date: May 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 4, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Mariposa Community Health Center	Nogales	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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