ACHIEVE Hearing Intervention Follow-Up Study

Randomized Trial of Telehealth vs. Conventional Hearing Care Delivery in the ACHIEVE Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Hearing Loss
• Intervention / Treatment: Other: Clinic-based audiological rehabilitative service delivery; Other: Telehealth audiological rehabilitative service delivery

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.

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Johns Hopkins Comstock Center for Public Health Research and Prevention
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • University of Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years to 88 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional hearing healthcare group; 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.	Other: Clinic-based audiological rehabilitative service delivery; Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks.; Other Names: Conventional hearing healthcare; Other: Telehealth audiological rehabilitative service delivery; Participants' scheduled clinic-based visits will be complemented with asynchronous and synchronous telehealth that will allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. At an initial session, participants will be instructed in the use of a study-provided, internet-enabled tablet device for telehealth sessions, re-introduced to the hearing loss toolkit for self-management and C2Hear Reusable Learning Objects within the context of the telehealth platform, re-evaluated on the Client Oriented Scale of Improvement (COSI) goals. Two remote follow-up sessions will be scheduled 3 and 6 weeks later to confirm participants' comfort with the telehealth platform and then completed every 6 months, in addition to scheduled 6-month clinic-based visits.; Other Names: Telehealth hearing healthcare
Other: Telehealth hearing healthcare group; 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.	Other: Telehealth audiological rehabilitative service delivery; Participants' scheduled clinic-based visits will be complemented with asynchronous and synchronous telehealth that will allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. At an initial session, participants will be instructed in the use of a study-provided, internet-enabled tablet device for telehealth sessions, re-introduced to the hearing loss toolkit for self-management and C2Hear Reusable Learning Objects within the context of the telehealth platform, re-evaluated on the Client Oriented Scale of Improvement (COSI) goals. Two remote follow-up sessions will be scheduled 3 and 6 weeks later to confirm participants' comfort with the telehealth platform and then completed every 6 months, in addition to scheduled 6-month clinic-based visits.; Other Names: Telehealth hearing healthcare

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily hours of hearing aid use	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.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing-specific quality of life as assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) questionnaire	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.	1 year
Treatment satisfaction as assessed by a single item from the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) scale	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.	1 year
Ability to hear for primary communication goal as assessed by a single item from the Client-Oriented Scale of Improvement (COSI) goals achievement questionnaire	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.	1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: University of South Florida; University of Minnesota; National Institute on Deafness and Other Communication Disorders (NIDCD); University of Mississippi Medical Center; University of North Carolina; Wake Forest University
• Investigators: Principal Investigator: Victoria A Sanchez, AuD, PhD, University of South Florida; Principal Investigator: Frank R Lin, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Actual): January 10, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: hearing healthcare; telehealth hearing healthcare; clinic-based hearing healthcare; hearing healthcare service delivery models
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: IRB00284937; R01DC019408 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The ACHIEVE data coordinating center, in coordination with the Steering Committee and NIH, will prepare a public access data release that complies with prevailing NIH and HIPAA guidelines in place when the study has been completed. Any participant identifying information will be removed.
• IPD Sharing Time Frame: We will share data 1 year following publication of the main results paper for the trial, unless NIH policy dictates that data be shared sooner.
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No