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Completed

NCT Number: NCT03864003

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mariposa Community Health Center

Nogales, Arizona, 85621, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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