ACHIEVE Hearing Intervention Follow-Up Study
ACHIEVE-HIFU
Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study
2 other identifiers
interventional
339
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedStudy Start
First participant enrolled
November 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2024
CompletedResults Posted
Study results publicly available
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2025
CompletedJune 11, 2026
May 1, 2026
2.2 years
September 27, 2021
January 2, 2025
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Daily Hours of Hearing Aid Use
Average daily hours of hearing aid use is obtained using objective hearing aid data logging. If a participant wears a hearing aid in both ears, then the ear with the greatest number of hours will be selected.
Up to 1 year
Secondary Outcomes (3)
Treatment Satisfaction as Assessed by a Single Item From the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) Scale
1 year
Ability to Hear for Primary Communication Goal as Assessed by a Single Item From the Client-Oriented Scale of Improvement (COSI) Goals Achievement Questionnaire
1 year
Hearing-specific Quality of Life as Assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) Questionnaire
1 year
Other Outcomes (1)
Average Daily Hours of Hearing Aid Use Through Two Years of Follow-up
Up to 2 years
Study Arms (2)
Conventional hearing healthcare group
OTHERThe 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.
Telehealth hearing healthcare group
OTHERThe 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.
Interventions
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.
Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks.
Eligibility Criteria
You may qualify if:
- Age 70-84 years
- Community-dwelling, fluent English speaker
- Availability of participant in area for study duration
- Adult-onset hearing impairment, defined as four-frequency pure tone average (PTA, 0.5-4 kilohertz (kHz), better ear) ≥30 decibel (dB) hearing level (HL) (decibels hearing level) \& \<70 dB HL
- Speech recognition scores in quiet ≥60% in better ear
- Mini-Mental State Exam (MMSE) score ≥23 for participants with high school degree or less, or ≥25 for participants with some college education or more
You may not qualify if:
- Reported disability in ≥2 activities of daily living (ADLs)
- Vision impairment (worse than 20/63 on the Minnesota Near Vision Card)
- Self-reported use of a hearing aid in the past 1 year
- Medical contraindication to use of hearing aids (e.g., draining ear)
- Unwilling to wear hearing aids on a daily basis
- Conductive hearing impairment with air-bone gap \>15 dB in two or more contiguous frequencies in both ears
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of North Carolinacollaborator
- University of South Floridacollaborator
- University of Minnesotacollaborator
- University of Mississippi Medical Centercollaborator
- Wake Forest Universitycollaborator
- NYU Langone Healthcollaborator
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
Study Sites (4)
Johns Hopkins Comstock Center for Public Health Research and Prevention
Hagerstown, Maryland, 21740, United States
University of Minnesota
Minneapolis, Minnesota, 55415, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Wake Forest University
Winston-Salem, North Carolina, 27104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Gravens-Mueller, Biostatistician/Supervisor
- Organization
- University of North Carolina, Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Frank R Lin, MD, PhD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Victoria A Sanchez, AuD, PhD
University of South Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 7, 2021
Study Start
November 12, 2021
Primary Completion
January 10, 2024
Study Completion
June 19, 2025
Last Updated
June 11, 2026
Results First Posted
January 31, 2025
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- We will share data 1 year following publication of the main results paper for the trial, unless NIH policy dictates that data be shared sooner.
- Access Criteria
- To be determined
The ACHIEVE data coordinating center, in coordination with the Steering Committee and NIH, will prepare a public access data release that complies with prevailing NIH and HIPAA guidelines in place when the study has been completed. Any participant identifying information will be removed.