Hearing LossACHIEVE-HIFUNCT05070429
ACHIEVE Hearing Intervention Follow-Up Study
A study testing Clinic-based audiological rehabilitative service delivery and Telehealth audiological rehabilitative service delivery in people with Hearing Loss and Aging, run by Johns Hopkins University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 73 to 88 years
- Conditions the study is for
- Hearing Loss, Aging
- What is being tested?
- Clinic-based audiological rehabilitative service delivery and Telehealth audiological rehabilitative service delivery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Nov 2021to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 73 to 88 years
- All sexes
- No healthy volunteers
- Older adult
To be eligible for the current study, participants must:
- have been eligible for and participated in the hearing intervention arm of the ACHIEVE trial (see original eligibility criteria below)
- agree to be randomized to receive continued hearing care via either a telehealth or conventional delivery model, and
- agree to participate in the follow-up study.
Original ACHIEVE Inclusion Criteria:
- 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
Original ACHIEVE Exclusion Criteria:
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Comstock Center for Public Health Research and Prevention
Hagerstown, Maryland, 21740
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Minnesota
Minneapolis, Minnesota, 55415
Wake Forest University
Winston-Salem, North Carolina, 27104
About this study
Official title: Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study
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.
Read the detailed description
This study is a multi-site randomized efficacy 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.
Participants will be recruited from the ongoing Aging \& Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial in which the investigators recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019 who were randomized to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention (i.e., one-on-one sessions with a health educator on topics important for healthy aging). From 2021-2022, as participants in the hearing intervention group (fixed sample, n=490) complete the pre-specified three years of follow-up in the ACHIEVE trial, the investigators will recruit these existing hearing aid users and randomize the participants 1:1 to receive continued conventional clinic-based delivery of hearing care services versus a model that incorporates telehealth. Accounting for loss to follow-up and death, the investigators conservatively estimate that n=400 participants currently in the hearing intervention group will be recruited into this two-year follow-up study.
The main analyses will be conducted at one-year post-randomization when hours of hearing aid use (primary outcome) and patient-centered hearing and communication, social functioning, and quality of life secondary outcomes will be contrasted between the two intervention groups.
After one year of follow-up, participants randomized to the conventional HHC arm will cross-over and also receive telehealth HHC, while participants randomized to the telehealth HHC arm will continue to receive telehealth HHC. All participants will continue to be followed for 2 years post-randomization for observational analyses, with data collection follow-up visits occurring every 6 months.
- Conditions
- Hearing Loss, Aging
- Being tested
- Clinic-based audiological rehabilitative service delivery, Telehealth audiological rehabilitative service delivery
- Keywords
- hearing healthcare, telehealth hearing healthcare, clinic-based hearing healthcare, hearing healthcare service delivery models
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based audiological rehabilitative service deliveryOther
Also called Conventional hearing healthcare
Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks.
Telehealth audiological rehabilitative service deliveryOther
Also called Telehealth hearing healthcare
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional hearing healthcare group | Other | 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. Receives: Other: Clinic-based audiological rehabilitative service delivery; Other: Telehealth audiological rehabilitative service delivery |
| Telehealth hearing healthcare group | Other | 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. Receives: Other: Telehealth audiological rehabilitative service delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The IOI-CHI is an interviewer-administered scale that consists of 6 items where participants self-report satisfaction with the hearing intervention using a 5-point Likert scale; treatment satisfaction is based on the item "Considering everything, do you think your present hearing intervention is worth the trouble?"), with scores ranging from 1 to 5 and higher scores indicating more treatment satisfaction.
Measured: 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
Achievement of COSI goals will be assessed by asking participants to rate their current ability to hear for their primary goal using a 5-point Likert scale, with options 1=hardly ever (10%), 2=occasionally (25%), 3=half of the time (50%), 4=most of the time (75%), and 5=almost always (95%), where higher scores indicate greater ability to hear. Mean of participant scale choice is reported.
Measured: 1 year
Hearing-specific Quality of Life as Assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) Questionnaire
The HHIE-S is an interviewer-administered questionnaire that consists of 10 items; participants rate whether hearing loss affects them in different situations (yes, sometimes, or no); the total score is the sum of all responses and ranges from 0 to 40, with higher scores indicating greater hearing issues.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start12 Nov 2021
- Primary completion10 Jan 2024
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of South Florida, University of Minnesota, University of Mississippi Medical Center, Wake Forest University, National Institute on Deafness and Other Communication Disorders (NIDCD), NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Frank R Lin, MD, PhD, Principal investigator, Johns Hopkins UniversityVictoria A Sanchez, AuD, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070429
- Sponsor's protocol ID
- IRB00284937
- Other IDs
- R01DC019408
- Acronym
- ACHIEVE-HIFU
- Status last verified
- May 2026
- First submitted
- 27 Sep 2021
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study
- ClinicalTrials.gov ID
- NCT05070429
- Acronym / sponsor ID
- ACHIEVE-HIFU / IRB00284937
- Conditions
- Hearing Loss, Aging
- Keywords
- hearing healthcare, telehealth hearing healthcare, clinic-based hearing healthcare, hearing healthcare service delivery models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, University of South Florida, University of Minnesota, University of Mississippi Medical Center, Wake Forest University, National Institute on Deafness and Other Communication Disorders (NIDCD), NYU Langone Health
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multi-site randomized efficacy 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.
Participants will be recruited from the ongoing Aging \& Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial in which the investigators recruited 977 adults ages 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019 who were randomized to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention (i.e., one-on-one sessions with a health educator on topics important for healthy aging). From 2021-2022, as participants in the hearing intervention group (fixed sample, n=490) complete the pre-specified three years of follow-up in the ACHIEVE trial, the investigators will recruit these existing hearing aid users and randomize the participants 1:1 to receive continued conventional clinic-based delivery of hearing care services versus a model that incorporates telehealth. Accounting for loss to follow-up and death, the investigators conservatively estimate that n=400 participants currently in the hearing intervention group will be recruited into this two-year follow-up study.
The main analyses will be conducted at one-year post-randomization when hours of hearing aid use (primary outcome) and patient-centered hearing and communication, social functioning, and quality of life secondary outcomes will be contrasted between the two intervention groups.
After one year of follow-up, participants randomized to the conventional HHC arm will cross-over and also receive telehealth HHC, while participants randomized to the telehealth HHC arm will continue to receive telehealth HHC. All participants will continue to be followed for 2 years post-randomization for observational analyses, with data collection follow-up visits occurring every 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional hearing healthcare group | Other | Other: Clinic-based audiological rehabilitative service delivery, Other: Telehealth audiological rehabilitative service deliveryThe 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 | Other | Other: Telehealth audiological rehabilitative service deliveryThe 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. |
Who may qualify
- Ages
- 73 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-based audiological rehabilitative service deliveryAlso: Conventional hearing healthcareParticipants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks. | Other | Conventional hearing healthcare group |
| Telehealth audiological rehabilitative service deliveryAlso: Telehealth hearing healthcareParticipants' 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. | Other | Conventional hearing healthcare group, Telehealth hearing healthcare group |
Primary outcome
Average Daily Hours of Hearing Aid Use
Time frame: Up to 1 year
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.
3 secondary outcomes
Treatment Satisfaction as Assessed by a Single Item From the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) Scale
Time frame: 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
Time frame: 1 year
Hearing-specific Quality of Life as Assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) Questionnaire
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank R Lin, MD, PhD principal investigator
Johns Hopkins University
Victoria A Sanchez, AuD, PhD principal investigator
University of South Florida
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-based audiological rehabilitative service delivery and Telehealth audiological rehabilitative service delivery in people with Hearing Loss and Aging, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Hours of Hearing Aid Use (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.