achieve hearing intervention follow-up study

Conditions: Hearing Loss; Aging

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.

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.

Eligibility 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

Keywords: hearing healthcare telehealth hearing healthcare clinic-based hearing healthcare hearing healthcare service delivery models