ACHIEVE Hearing Intervention Follow-Up Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hearing Loss, Aging

Intervention / Treatment
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* Other: Clinic-based audiological rehabilitative service delivery
* Other: Telehealth audiological rehabilitative service delivery


Participation Criteria
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Eligibility Criteria
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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 dB 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

Ages Eligible for Study
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Minimum Age: 73 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional hearing healthcare group<br>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<br>* Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks.<br>* Other names: Conventional hearing healthcare;Other: Telehealth audiological rehabilitative service delivery<br>* 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.<br>* Other names: Telehealth hearing healthcare;|
| Other: Telehealth hearing healthcare group<br>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<br>* 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.<br>* Other names: Telehealth hearing healthcare;|

What is the study measuring?
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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 | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction as assessed by 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; scores are summed across all items (range 6 to 30), with higher scores indicating a more favorable outcome. | 1 year | 
| Change in hearing ability for primary communication goal as assessed by the Client-Oriented Scale of Improvement (COSI) goals achievement | Achievement of COSI goals is assessed by asking participants to rate the degree of change in hearing ability since randomization for their primary goal using a 4-point Likert scale, with higher scores indicating more improvement. | Baseline and 1 year | 
| Ability to hear for primary communication goal as assessed by the 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 | 
| 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 | 
| Aided speech recognition in noise total words correct as assessed by the Quick Speech-in-Noise (QuickSIN) Test | The QuickSIN test consists of 6 sentences, each containing 5 key words; scoring is based on how many of the key words the participant correctly repeats back, with total score ranging from 0 to 30 words. | 1 year | 
| Social engagement as assessed by the Cohen's Social Network Index (SNI) questionnaire | The Cohen's SNI questionnaire asks about the number of people the participant has regular contact with (at least once every 2 weeks) within each of 12 different possible settings/types of contacts (e.g., relatives, church members, neighbors, etc.); social engagement is quantified by summing the total number of people in the social network across all 12 settings/roles. | 1 year | 
| Loneliness as assessed by the University of California Los Angeles (UCLA) Loneliness scale | The UCLA Loneliness scale is interviewer-administered and consists of 20 items that participants rate using a 4-point Likert scale; 10 positively worded items are reverse-coded, and average scores range from 1 to 4, with higher scores indicating greater expression of loneliness. | 1 year | 
| Physical health as assessed by the RAND 36-Item Health Survey | The RAND 36-Item Health Survey is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the physical component score is a factor-analytically derived score with normative mean of 50 and standard deviation of 10 (range 0 to 100); higher scores indicate better physical health. | 1 year | 
| Mental health as assessed by the RAND 36-Item Health Survey | The RAND 36-Item Health Survey is an interviewer-administered scale measuring a person's perceptions of their health and health-related quality of life; the mental component score is a factor-analytically derived score with normative mean of 50 and standard deviation of 10 (range 0 to 100); higher scores indicate better mental health. | 1 year | 
| Depressive symptoms as assessed by the Center for Epidemiological Studies Depression Scale (CES-D) | The CES-D is an interviewer-administered scale that consists of 12 items which participants rate using a 3-point Likert scale; 2 positively worded items are reverse-coded; the first 11 items are summed to create a total score ranging from 0 to 22, with higher scores indicating greater expression of depression. The 12th item is a rating of hopelessness that is not included in the total score. | 1 year | 
| Total number of contacts between provider and participant | The total number of provider-participant contacts is quantified by the study audiologists using forms completed at every encounter. | Up to 1 year | 
| Total time spent between provider and participant | The total time spent (minutes) between provider and participant is quantified by the study audiologists using forms completed at every encounter. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing healthcare, telehealth hearing healthcare, clinic-based hearing healthcare, hearing healthcare service delivery models