Nested Trial of Telehealth versus Conventional Hearing Care in ACHIEVE

Reed, Nicholas; Fakhreddin, Randy; Arnold, Michelle; Calloway, Haley; Chisolm, Theresa; Deal, Jennifer; Burgard, Sheila; Goman, Adele; Gravens-Mueller, Lisa; Huang, Alison; Mitchell, Christine; Pike, James; Coresh, Josef; Lin, Frank; Sanchez, Victoria

Abstract

Objectives: The Aging & Cognitive Health Evaluation in Elders (ACHIEVE) was a randomized control trial of hearing intervention against a health education control on 3-year cognitive trajectories (n=977) at four sites in the United States (Jackson, MS, Forsyth County, NC, Minneapolis, MN, Washington County, MD).
The ACHIEVE Hearing Intervention Follow-Up (HIFU) study [Clinicaltrials.gov NCT05070429; NIH funded R01DC019408] is a nested randomized trial that compared 1-year daily hours of hearing aid use (primary) and hearing and communication outcomes (secondary) between telehealth (experimental) and a continuation of conventional in-person hearing care (control) models.
Design: Participants in the hearing intervention arm of the ACHIEVE parent trial who attended all intervention visits and were willing to be randomized were eligible for the ACHIEVE HIFU study. Eligibility for the initial ACHIEVE trial further included being community-dwelling, between 70-84 years, better-ear 4-frequency (0.5 to 4 kHz) pure-tone average ≥30 and<70 dB, and Mini-Mental State Exam ≥23
for ≤ high school degree; ≥25 for ≥ some college. Consented participants were randomized to continued conventional in-person care (control) or a telehealth audiology care model (experimental) arm characterized by synchronous and asynchronous telehealth support provided through the GrandPad™ tablet (GrandPad, Minnetonka, MN) designed for use by older adults. An accompanying abstract to the 2025 American Auditory Society Meeting will describe the intervention design and implementation in
detail. Daily hours of hearing aid use from hearing aid software [primary outcome], Hearing Handicap Inventory for the Elderly-Screener (HHIE-S), and International Outcome Inventory for Hearing Aids were measured 1-year post randomization. One-year outcomes were compared between groups using attrition-weighted regression model with an identity link and a bias corrected and accelerated bootstrap resampling procedure (10,000 replicants) to account for non-normal distribution of the primary outcome. Planned sensitivity analyses included the use of self-reported hours of use (as opposed to
device reported), inclusion of an interaction variable for recruitment source, and restriction by hearing aid type (e.g., technology level).
Results: 339 of 490 participants in the ACHIEVE intervention arm enrolled in ACHIEVE HIFU (54.9% female, mean age=78.9 years (SD=3.9), 89.1% White, 54% with at least some college, mini-mental state exam mean=28.2 (SD=1.8), and 4-frequency pure-tone average mean=42.7 (SD=7.9)). Distribution of baseline variables were similar between the telehealth (n=163) and continued conventional care (n=176) groups. Overall, no statistical differences were found at one-year post intervention on any primary or secondary outcomes. One-year device-derived hours of hearing aid use were 7.2 (SD=5.0) in the
telehealth intervention and 7.4 (SD=5.2) in the conventional care arms (β=0.119; 95%CI=-0.394,0.632; p=0.65). One-year HHIE-S scores were 7.4 (SD=5.0) and 7.6 (SD=7.1) in the telehealth and conventional delivery arms, respectively (β=-0.925; 95%CI=-2.924,1.074; p=0.36). Further, a prior sensitivity analyses
revealed no differences by recruitment source or hearing aid technology level nor when using self-reported daily hours of hearing aid use.
Conclusions: No statistical differences were observed 1-year post randomization to telehealth and conventional hearing care delivery arms. The inherent superiority design of the trial limits inference on equivalence of models. However, future studies designed to assess non-inferiority or equivalence between modes that include cost-efficiency analyses are warranted as telehealth may represent a patient-centered alternative to standard in-person care among older adults when designed with patient-centered needs in mind

Citation

Reed, N., Fakhreddin, R., Arnold, M., Calloway, H., Chisolm, T., Deal, J., Burgard, S., Goman, A., Gravens-Mueller, L., Huang, A., Mitchell, C., Pike, J., Coresh, J., Lin, F., & Sanchez, V. (2024, February). Nested Trial of Telehealth versus Conventional Hearing Care in ACHIEVE. Presented at American Auditory Society 52nd Annual Scientific and Technology Meeting, Scottsdale, Arizona, USA

• Presentation Conference Type: Conference Abstract
• Conference Name: American Auditory Society 52nd Annual Scientific and Technology Meeting
• Start Date: Feb 13, 2024
• End Date: Feb 15, 2024
• Deposit Date: Jan 16, 2025
• Peer Reviewed: Not Peer Reviewed
• Publisher URL: https://aas.memberclicks.net/assets/docs/2025_Podiums.pdf