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Audiology Services via Telehealth for Hearing Loss in Aging

N/A

Waitlist Available

Led By Frank R Lin, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have been eligible for and participated in the hearing intervention arm of the ACHIEVE trial

Age 70-84 years

Must not have

Conductive hearing impairment with air-bone gap >15 dB in two or more contiguous frequencies in both ears

Unwillingness to wear hearing aids on a daily basis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a telehealth hearing healthcare model is better than the conventional clinic-based model in improving hearing aid use and communication outcomes in older adults.

Who is the study for?

This trial is for older adults aged 70-84 with adult-onset hearing loss who previously participated in the ACHIEVE trial. They must have a mild to moderate hearing impairment and be open to using telehealth or clinic-based hearing care. Exclusions include severe vision impairment, recent use of hearing aids, unwillingness to wear them daily, certain ear conditions, and significant disability in daily activities.

What is being tested?

The study compares two ways of delivering hearing healthcare: traditional in-clinic visits versus telehealth services. It aims to see if telehealth can improve how often older adults use their hearing aids and other communication outcomes compared to standard clinic visits.

What are the potential side effects?

Since this trial involves service delivery methods rather than medications, there are no direct side effects like those associated with drugs. However, participants may experience differences in satisfaction or effectiveness between the two models.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was part of the hearing intervention in the ACHIEVE trial.

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I am between 70 and 84 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hearing loss where sounds don't reach my inner ear well in both ears.

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I am not willing to wear hearing aids every day.

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I need help with two or more daily activities like eating or dressing.

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I cannot use hearing aids due to a medical issue like draining ear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average daily hours of hearing aid use

Secondary study objectives

Ability to hear for primary communication goal as assessed by a single item from the Client-Oriented Scale of Improvement (COSI) goals achievement questionnaire

Hearing-specific quality of life as assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) questionnaire

Treatment satisfaction as assessed by a single item from the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Telehealth hearing healthcare groupExperimental Treatment1 Intervention

The telehealth hearing healthcare group will have clinic-based visits every 6 months for the duration of the 2-year study. This group will receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth options, in addition to conventional options, to address any unanticipated needs that arise during both years of the study.

Group II: Conventional hearing healthcare groupExperimental Treatment2 Interventions

The conventional hearing healthcare group will have clinic-based visits every 6 months for the duration of the 2-year study. During Year 1, this group will receive clinic-based audiological rehabilitative service delivery and be able to use conventional options to address any unanticipated needs that arise, and then during Year 2, this group will also receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth options, in addition to conventional options, to address any unanticipated needs that arise.

0 / 6Eligibility criteria met