Audiology Services via Telehealth for Hearing Loss in Aging

Recruiting at 3 trial locations

Overseen By Christine Mitchell, ScM

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Disability in ADLs, Vision impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 1 year

339 Participants Needed

Trial Summary

What is the purpose of this trial?

The ACHIEVE Hearing Intervention Follow-Up study is a randomized trial of a telehealth versus conventional clinic-based hearing healthcare (HHC) delivery model among older adults who are existing hearing aid users to determine if a telehealth HHC model improves hearing aid use and other communication outcomes compared to clinic-based HHC.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of telehealth audiological rehabilitative service delivery for hearing loss in aging?

Research shows that telehealth applications in audiology, including hearing aid support and rehabilitation, are effective and reliable compared to traditional methods. These services can improve access to care and patient satisfaction, especially for underserved communities. ^{1 2 3 4 5}

Is telehealth for audiology services safe for humans?

Research shows that telehealth in audiology is generally safe and effective, providing reliable results for hearing tests and treatments similar to traditional in-person methods. It has been successfully used for various services, including hearing aid verification and counseling, without significant safety concerns. ^{1 3 6 7 8}

How does telehealth audiological rehabilitative service delivery differ from other treatments for hearing loss in aging?

Telehealth audiological rehabilitative service delivery is unique because it allows patients to receive hearing care remotely, breaking down geographic barriers and reaching underserved communities. This approach is cost-effective, quick, and can provide personalized rehabilitation, making it a promising alternative to traditional in-person audiology services. ^{1 2 4 7 8}

Research Team

Frank R Lin, MD, PhD

Principal Investigator

Johns Hopkins University

Victoria A Sanchez, AuD, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

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.

Inclusion Criteria

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

You have moderate to severe hearing loss in your better ear.

Availability of participant in area for study duration

Exclusion Criteria

I am not willing to wear hearing aids every day.

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

You have used a hearing aid in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either telehealth or conventional clinic-based hearing healthcare services

1 year

Clinic-based visits every 6 months

Crossover

Participants in the conventional HHC arm cross-over to receive telehealth HHC

1 year

Clinic-based visits every 6 months

Follow-up

Participants are monitored for hearing aid use and communication outcomes

2 years

Data collection follow-up visits every 6 months

Treatment Details

Interventions

• Clinic-based audiological rehabilitative service delivery
• Telehealth audiological rehabilitative service delivery

Trial Overview 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.

Participant Groups

Group I: Telehealth hearing healthcare group Experimental Treatment 1 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 group Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth applications in audiology. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Remote Hearing Aid Support: The Next Frontier. [2022]

3. England pubmed.ncbi.nlm.nih.gov

eHealth and the hearing aid adult patient journey: a state-of-the-art review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Connected Audiological Rehabilitation: 21st Century Innovations. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to delivery of group audiological rehabilitation programs: a survey based on the COM-B model. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

U.S. Policy Considerations for Telehealth Provision in Audiology. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Telehealth in audiology: an integrative review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Stories From the Webcams: Cincinnati Children's Hospital Medical Center Audiology Telehealth and Pediatric Auditory Device Services. [2022]