Aging, Hearing Loss
Conditions
Keywords
hearing healthcare, telehealth hearing healthcare, clinic-based hearing healthcare, hearing healthcare service delivery models
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.
Interventions
OTHERClinic-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.
OTHERTelehealth 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.
Sponsors
Johns Hopkins University
University of North Carolina
University of South Florida
University of Minnesota
University of Mississippi Medical Center
Wake Forest University
National Institute on Deafness and Other Communication Disorders (NIDCD)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
73 Years to 88 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 their current ability to hear for their primary goal using a 5-point Likert scale, with options 1=hardly ever (10%), 2=occasionally (25%), 3=half of the time (50%), 4=most of the time (75%), and 5=almost always (95%), where higher scores indicate greater ability to hear. Mean of participant scale choice is reported. |
| 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 40, with higher scores indicating greater hearing issues. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrank R Lin, MD, PhD
Johns Hopkins University
PRINCIPAL_INVESTIGATORVictoria A Sanchez, AuD, PhD
University of South Florida
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Hearing Healthcare Group The conventional hearing group will have clinic-based visits every 6 months for the 2-year study. During Year 1, they will receive clinic-based audiological rehabilitative service and use conventional options to address unanticipated needs. During Year 2, this group will also receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth, and conventional options, to address any unanticipated needs.
Clinic-based audiological rehabilitative service: Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and hearing aid checks.
Telehealth audiological rehabilitative service: Participants' scheduled clinic-based visits will be complemented with asynchronous and synchronous telehealth that will allow for routine troubleshooting of communication challenges, hearing aid issues, and reinforcement of self-management support strategies. At an initial session, participants will be instructed in the use of, an 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 goals. Two remote follow-up sessions will be scheduled 3 and 6 weeks later to confirm participants' comfort with the telehealth platform, completed every 6 months, and scheduled 6-month clinic-based visits. | 176 |
| 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.
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. | 163 |
| Total | 339 |
Baseline characteristics
| Characteristic | Telehealth Hearing Healthcare Group | Conventional Hearing Healthcare Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 163 Participants | 176 Participants | 339 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79.1 years STANDARD_DEVIATION 4 | 78.7 years STANDARD_DEVIATION 3.8 | 78.9 years STANDARD_DEVIATION 3.9 |
| Age, Customized Age in Categories 75 - 79 years | 65 Participants | 82 Participants | 147 Participants |
| Age, Customized Age in Categories 80 - 84 years | 56 Participants | 53 Participants | 109 Participants |
| Age, Customized Age in Categories 85 - 88 years | 20 Participants | 14 Participants | 34 Participants |
| Age, Customized Age in Categories Between 72 and 74 years | 22 Participants | 27 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants | 170 Participants | 328 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 17 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 145 Participants | 157 Participants | 302 Participants |
| Region of Enrollment United States | 163 Participants | 176 Participants | 339 Participants |
| Sex: Female, Male Female | 87 Participants | 99 Participants | 186 Participants |
| Sex: Female, Male Male | 76 Participants | 77 Participants | 153 Participants |
| Site Forsyth County, NC | 35 Participants | 37 Participants | 72 Participants |
| Site Jackson, MS | 39 Participants | 45 Participants | 84 Participants |
| Site Minneapolis, MN | 42 Participants | 43 Participants | 85 Participants |
| Site Washington County, MD | 47 Participants | 51 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 176 | 4 / 163 |
| other Total, other adverse events | 7 / 176 | 11 / 163 |
| serious Total, serious adverse events | 0 / 176 | 0 / 163 |
Outcome results
Primary
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.
Time frame: Up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Hearing Healthcare Group | Average Daily Hours of Hearing Aid Use | 7.37 Daily hours | Standard Deviation 5.15 |
| Telehealth Hearing Healthcare Group | Average Daily Hours of Hearing Aid Use | 7.20 Daily hours | Standard Deviation 5.05 |
Comparison: Used a weighted regression model with an identity link to compare average daily hours of hearing aid use at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the primary outcome.p-value: 0.9295% CI: [-0.727, 0.657]generalized linear model (GLM)
Secondary
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 their current ability to hear for their primary goal using a 5-point Likert scale, with options 1=hardly ever (10%), 2=occasionally (25%), 3=half of the time (50%), 4=most of the time (75%), and 5=almost always (95%), where higher scores indicate greater ability to hear. Mean of participant scale choice is reported.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Hearing Healthcare Group | Ability to Hear for Primary Communication Goal as Assessed by a Single Item From the Client-Oriented Scale of Improvement (COSI) Goals Achievement Questionnaire | 4.25 score on a scale | Standard Deviation 0.74 |
| Telehealth Hearing Healthcare Group | Ability to Hear for Primary Communication Goal as Assessed by a Single Item From the Client-Oriented Scale of Improvement (COSI) Goals Achievement Questionnaire | 4.29 score on a scale | Standard Deviation 0.69 |
Comparison: Used a weighted regression model with an identity link to compare primary COSI goal achievement at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.p-value: 0.6695% CI: [-0.201, 0.32]generalized linear model (GLM)
Secondary
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 40, with higher scores indicating greater hearing issues.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Hearing Healthcare Group | Hearing-specific Quality of Life as Assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) Questionnaire | 7.33 units on a scale | Standard Deviation 7.1 |
| Telehealth Hearing Healthcare Group | Hearing-specific Quality of Life as Assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) Questionnaire | 7.16 units on a scale | Standard Deviation 6.49 |
Comparison: Used a weighted regression model with an identity link to compare hearing-specific quality of life at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.p-value: 0.3895% CI: [-6.349, 2.435]generalized linear model (GLM)
Secondary
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Hearing Healthcare Group | Treatment Satisfaction as Assessed by a Single Item From the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) Scale | 4.78 score on a scale | Standard Deviation 0.47 |
| Telehealth Hearing Healthcare Group | Treatment Satisfaction as Assessed by a Single Item From the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) Scale | 4.78 score on a scale | Standard Deviation 0.44 |
Comparison: Used a weighted regression model with an identity link to compare treatment satisfaction at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.p-value: 0.8795% CI: [-0.147, 0.125]generalized linear model (GLM)
Other Pre-specified
Average Daily Hours of Hearing Aid Use Through Two Years of Follow-up
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.
Time frame: Up to 2 years