R01DC019408

Randomized Trial of Telehealth vs Conventional Hearing Care Delivery in the Achieve Study - Project Summary

Hearing loss is a chronic condition prevalent in two-thirds of adults over 70 years old and may be a potentially modifiable risk factor for adverse health outcomes, including dementia. However, the uptake and sustained use of hearing aids in adults is low, with less than 20% of older adults with hearing loss reporting use. Among those who do use hearing aids, up to 30-40% may discontinue use over time. These limitations may stem in part from the reliance of the current best-practice model of hearing healthcare (HHC) on clinic-based visits that require multiple in-person sessions between an audiologist and a patient for all ongoing technical and self-management support services.

Incorporation of asynchronous and synchronous telehealth into HHC to complement clinic-based visits would allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. Determining if an HHC model that incorporates audiological telehealth improves long-term hearing aid use and other patient-centered outcome measures has direct implications for both future clinical care standards and ongoing Medicare legislative bills pertaining to HHC coverage.

Our interdisciplinary consortium of investigators has a singular opportunity to evaluate the potential benefits of a telehealth audiology model on long-term hearing aid use and other outcomes in a large cohort of racially-diverse, community-dwelling older adults who are existing hearing aid users. In the ongoing Aging & Cognitive Health Evaluation in Elders (ACHIEVE) randomized trial, we recruited 977 adults aged 70-84 with untreated mild-to-moderate hearing loss from January 2018 to October 2019. These participants were randomized 1:1 to a hearing intervention (i.e., conventional clinic-based delivery of hearing services and technologies) versus a successful aging education control intervention. Participants are now being followed for 3 years post-randomization at the four ACHIEVE field sites. The goal of this NIA-funded multisite trial (R01AG055426) is to determine if hearing loss treatment versus an aging education control intervention reduces cognitive decline.

From 2021-2022, as participants in the hearing intervention group (n=490) complete their pre-specified three years of follow-up in the ACHIEVE trial, we propose to recruit these existing hearing aid users and randomize them to receive either continued conventional clinic-based delivery of hearing care services or a model that incorporates telehealth. At 1 year post-randomization, the primary outcome (hours of hearing aid use) will be contrasted between the two groups. Participants in the conventional HHC arm will then cross-over and also receive telehealth HHC. All participants will continue to be followed for 2 years post-randomization.

Aim 1: To compare the effect of the telehealth versus conventional HHC delivery model on hours of hearing aid use (primary outcome) and other patient-centered hearing and communication outcomes at 1 year post-randomization.

Aim 2: To compare the effect of the telehealth versus the conventional HHC delivery model on secondary outcomes of social, mental, physical, and cognitive functioning at 1 year post-randomization.

The Johns Hopkins University

TO INVESTIGATE SOLUTIONS TO PROBLEMS DIRECTLY RELEVANT TO INDIVIDUALS WITH DEAFNESS OR DISORDERS OF HUMAN COMMUNICATION IN THE AREAS OF HEARING, BALANCE, SMELL, TASTE, VOICE, SPEECH, AND LANGUAGE. THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS (NIDCD) SUPPORTS RESEARCH AND RESEARCH TRAINING, INCLUDING INVESTIGATION INTO THE ETIOLOGY, PATHOLOGY, DETECTION, TREATMENT, AND PREVENTION OF DISORDERS OF HEARING AND OTHER COMMUNICATION PROCESSES, PRIMARILY THROUGH THE SUPPORT OF BASIC AND APPLIED RESEARCH IN ANATOMY, AUDIOLOGY, BIOCHEMISTRY, BIOENGINEERING, EPIDEMIOLOGY, GENETICS, IMMUNOLOGY, MICROBIOLOGY, MOLECULAR BIOLOGY, THE NEUROSCIENCES, OTOLARYNGOLOGY, PSYCHOLOGY, PHARMACOLOGY, PHYSIOLOGY, PSYCHOPHYSICS, SPEECH-LANGUAGE PATHOLOGY, AND OTHER SCIENTIFIC DISCIPLINES. THE NIDCD SUPPORTS: (1) RESEARCH INTO THE EVALUATION OF TECHNIQUES AND DEVICES USED IN DIAGNOSIS, TREATMENT, REHABILITATION, AND PREVENTION OF DISORDERS OF HEARING AND OTHER COMMUNICATION PROCESSES, (2) RESEARCH INTO PREVENTION AND EARLY DETECTION AND DIAGNOSIS OF HEARING LOSS AND SPEECH, VOICE, AND LANGUAGE DISORDERS AND RESEARCH INTO PREVENTING THE EFFECTS OF SUCH DISORDERS BY MEANS OF APPROPRIATE REFERRAL AND REHABILITATION, (3) RESEARCH INTO THE DETECTION, TREATMENT, AND PREVENTION OF DISORDERS OF HEARING AND OTHER COMMUNICATION PROCESSES IN THE ELDERLY POPULATION AND ITS REHABILITATION TO ENSURE CONTINUED EFFECTIVE COMMUNICATION SKILLS, AND (4) RESEARCH TO EXPAND KNOWLEDGE OF THE EFFECTS OF ENVIRONMENTAL AGENTS THAT INFLUENCE HEARING OR OTHER COMMUNICATION PROCESSES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO ENCOURAGE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.173 - Research Related to Deafness and Communication Disorders

National Institute on Deafness and Other Communication Disorders (NIDCD) [HHS - NIH]

Baltimore, Maryland 212870028 United States

Single Zip Code

Hearing Health Care for Adults: Improving Access and Affordability (R01 Clinical Trial Optional) (PA-18-438)

Amendment Since initial award the total obligations have increased 349% from $703,053 to $3,154,952.