ACHIEVE Hearing Intervention Follow-Up Study

NCT05070429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2025-09-09

Study results available
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Summary

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.

Conditions

Interventions

OTHER

Clinic-based audiological rehabilitative service delivery

Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks.

OTHER

Telehealth audiological rehabilitative service delivery

Participants' scheduled clinic-based visits will be complemented with asynchronous and synchronous telehealth that will allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. At an initial session, participants will be instructed in the use of a study-provided, internet-enabled tablet device for telehealth sessions, re-introduced to the hearing loss toolkit for self-management and C2Hear Reusable Learning Objects within the context of the telehealth platform, re-evaluated on the Client Oriented Scale of Improvement (COSI) goals. Two remote follow-up sessions will be scheduled 3 and 6 weeks later to confirm participants' comfort with the telehealth platform and then completed every 6 months, in addition to scheduled 6-month clinic-based visits.

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER
  • University of South Florida

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • University of Mississippi Medical Center

    collaborator OTHER
  • Wake Forest University

    collaborator OTHER
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH
  • NYU Langone Health

    collaborator OTHER
  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Frank R Lin, MD, PhD · Johns Hopkins University

  • Victoria A Sanchez, AuD, PhD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
73 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2024-01-10
Completion
2025-06-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05070429 on ClinicalTrials.gov