ACHIEVE Hearing Intervention Follow-Up Study
NCT05070429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339
Last updated 2025-09-09
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
- Hearing Loss
- Aging
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 - 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 - collaborator OTHER
- 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
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