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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC019408 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| University of South Florida | OTHER |
| University of Minnesota | OTHER |
| University of Mississippi Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional hearing healthcare group | Other | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic-based audiological rehabilitative service delivery | Other | Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
To be eligible for the current study, participants must:
Original ACHIEVE Inclusion Criteria:
Original ACHIEVE Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank R Lin, MD, PhD | Johns Hopkins University | Principal Investigator |
| Victoria A Sanchez, AuD, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Comstock Center for Public Health Research and Prevention | Hagerstown | Maryland | 21740 | United States | ||
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.
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.
To be determined
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Daily hours | Up to 1 year |
|
Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis externa | Ear and labyrinth disorders | Systematic Assessment | An inflammation, irritation, or infection of the external ear canal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Gravens-Mueller, Biostatistician/Supervisor | University of North Carolina, Chapel Hill | 919-962-3098 | lgravens@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2024 | Dec 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2024 | Dec 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| OTHER |
| Wake Forest University | OTHER |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| NYU Langone Health | OTHER |
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|
| Telehealth audiological rehabilitative service delivery | Other | 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. |
|
|
| 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 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. | 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 40, with higher scores indicating greater hearing issues. | 1 year |
| University of Minnesota |
| Minneapolis |
| Minnesota |
| 55415 |
| United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27104 | United States |
| Other |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Site | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
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|
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| 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. | Posted | May 2026 | Mean | Standard Deviation | Daily hours | Up to 2 years |
|
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|
| 0 |
| 176 |
| 0 |
| 176 |
| 7 |
| 176 |
| EG001 | 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. | 4 | 163 | 0 | 163 | 11 | 163 |
|
| Cerumen impaction | Ear and labyrinth disorders | Systematic Assessment | Earwax blockage |
|
| Other | Ear and labyrinth disorders | Systematic Assessment | Type B tympanogram right ear requiring medical evaluation; Extremely low blood pressure; Abnormal tympanograms associated with recent illness; Myringotomy LEFT ear following sudden hearing loss |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |