ACHIEVE Hearing Intervention Follow-Up Study (ACHIEVE-HIFU)

Johns Hopkins University

Status: Completed

Conditions: Aging; Hearing Loss

Treatments: Other: Clinic-based audiological rehabilitative service delivery; Other: Telehealth audiological rehabilitative service delivery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05070429

IRB00284937

R01DC019408 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 339 patients

Sex: All

Ages: 73 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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339 participants in 2 patient groups

Conventional hearing healthcare group

Other group

Description:

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.

Treatment:

Other: Telehealth audiological rehabilitative service delivery

Other: Clinic-based audiological rehabilitative service delivery

Telehealth hearing healthcare group

Other group

Description:

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.

Treatment:

Other: Telehealth audiological rehabilitative service delivery