ACHIEVE Hearing Intervention Follow-Up Study

NCT ID: NCT05070429

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-12
• Study Completion Date: 2025-06-19

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Conventional hearing healthcare group

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.

Group Type: OTHER

Clinic-based audiological rehabilitative service delivery

Intervention Type: OTHER

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 delivery

Intervention Type: OTHER

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.

Telehealth hearing healthcare group

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 Type: OTHER

Telehealth audiological rehabilitative service delivery

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Conventional hearing healthcare; Telehealth hearing healthcare

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

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

• Minimum Eligible Age: 73 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank R Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Victoria A Sanchez, AuD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Johns Hopkins Comstock Center for Public Health Research and Prevention

Hagerstown, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01DC019408

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00284937

Identifier Type: -

Identifier Source: org_study_id