ACHIEVE Hearing Intervention Follow-Up Study
- Conditions
- AgingHearing Loss
- Interventions
- Other: Clinic-based audiological rehabilitative service deliveryOther: Telehealth audiological rehabilitative service delivery
- Registration Number
- NCT05070429
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 339
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional hearing healthcare group Clinic-based audiological rehabilitative service delivery 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. Conventional hearing healthcare group Telehealth audiological rehabilitative service delivery 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. Telehealth hearing healthcare group Telehealth audiological rehabilitative service delivery 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.
- Primary Outcome Measures
Name Time Method Average daily hours of hearing aid use Up to 1 year Average daily hours of hearing aid use is obtained using objective hearing aid data logging. If a participant wears a hearing aid in both ears, then the ear with the greatest number of hours will be selected.
- Secondary Outcome Measures
Name Time Method Treatment satisfaction as assessed by a single item from the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) scale 1 year The IOI-CHI is an interviewer-administered scale that consists of 6 items where participants self-report satisfaction with the hearing intervention using a 5-point Likert scale; treatment satisfaction is based on the item "Considering everything, do you think your present hearing intervention is worth the trouble?"), with scores ranging from 1 to 5 and higher scores indicating more treatment satisfaction.
Ability to hear for primary communication goal as assessed by a single item from the Client-Oriented Scale of Improvement (COSI) goals achievement questionnaire 1 year Achievement of COSI goals will be assessed by asking participants to rate the current amount of time they are able to hear for their primary goal using a 5-point Likert scale, with higher scores indicating ability to hear more of the time.
Hearing-specific quality of life as assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) questionnaire 1 year The HHIE-S is an interviewer-administered questionnaire that consists of 10 items; participants rate whether hearing loss affects them in different situations (yes, sometimes, or no); the total score is the sum of all responses and ranges from 0 to 20, with higher scores indicating greater hearing issues.
Trial Locations
- Locations (4)
Johns Hopkins Comstock Center for Public Health Research and Prevention
🇺🇸Hagerstown, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States