Clinical trial NCT05070429: ACHIEVE Hearing Intervention Follow-Up Study
Official title: Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss
Aging
Keywords: hearing healthcare
telehealth hearing healthcare
clinic-based hearing healthcare
hearing healthcare service delivery models
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of South Florida
name: University of Minnesota
name: University of Mississippi Medical Center
name: Wake Forest University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-10-07
Enrollment: 339
Sex: ALL
Minimum age (years): 73
Maximum age (years): 88
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Average Daily Hours of Hearing Aid Use
timeFrame: Up to 1 year
Secondary outcomes:
measure: Treatment Satisfaction as Assessed by a Single Item From the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) Scale
timeFrame: 1 year
measure: Ability to Hear for Primary Communication Goal as Assessed by a Single Item From the Client-Oriented Scale of Improvement (COSI) Goals Achievement Questionnaire
timeFrame: 1 year
measure: Hearing-specific Quality of Life as Assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) Questionnaire
timeFrame: 1 year
Other outcomes:
measure: Average Daily Hours of Hearing Aid Use Through Two Years of Follow-up
timeFrame: Up to 2 years
Locations:
city: Hagerstown
country: United States
facility: Johns Hopkins Comstock Center for Public Health Research and Prevention
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Frank R Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Victoria A Sanchez, AuD, PhD
role: PRINCIPAL_INVESTIGATOR
References: