Trial Outcomes & Findings for ACHIEVE Hearing Intervention Follow-Up Study (NCT NCT05070429)
NCT ID: NCT05070429
Last Updated: 2025-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
339 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
163
|
|
Overall Study
COMPLETED
|
159
|
153
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Other
|
15
|
5
|
Baseline Characteristics
ACHIEVE Hearing Intervention Follow-Up Study
Baseline characteristics by cohort
| Measure |
Conventional Hearing Healthcare Group
n=176 Participants
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.
|
Telehealth Hearing Healthcare Group
n=163 Participants
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.
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
176 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
Age, Continuous
|
78.7 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
79.1 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
78.9 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Age, Customized
Age in Categories · Between 72 and 74 years
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Customized
Age in Categories · 75 - 79 years
|
82 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Age, Customized
Age in Categories · 80 - 84 years
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Customized
Age in Categories · 85 - 88 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
157 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
176 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
Site
Forsyth County, NC
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Site
Jackson, MS
|
45 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Site
Minneapolis, MN
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Site
Washington County, MD
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearAverage 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.
Outcome measures
| Measure |
Conventional Hearing Healthcare Group
n=159 Participants
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.
|
Telehealth Hearing Healthcare Group
n=153 Participants
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.
|
|---|---|---|
|
Average Daily Hours of Hearing Aid Use
|
7.37 Daily hours
Standard Deviation 5.15
|
7.20 Daily hours
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: 1 yearThe 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.
Outcome measures
| Measure |
Conventional Hearing Healthcare Group
n=159 Participants
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.
|
Telehealth Hearing Healthcare Group
n=153 Participants
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.
|
|---|---|---|
|
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
|
4.78 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 1 yearAchievement 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.
Outcome measures
| Measure |
Conventional Hearing Healthcare Group
n=159 Participants
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.
|
Telehealth Hearing Healthcare Group
n=153 Participants
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.
|
|---|---|---|
|
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
|
4.29 score on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 1 yearThe 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.
Outcome measures
| Measure |
Conventional Hearing Healthcare Group
n=159 Participants
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.
|
Telehealth Hearing Healthcare Group
n=153 Participants
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.
|
|---|---|---|
|
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 7.10
|
7.16 units on a scale
Standard Deviation 6.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsAverage 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.
Outcome measures
Outcome data not reported
Adverse Events
Conventional Hearing Healthcare Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Telehealth Hearing Healthcare Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Hearing Healthcare Group
n=176 participants at risk
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.
|
Telehealth Hearing Healthcare Group
n=163 participants at risk
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.
|
|---|---|---|
|
Ear and labyrinth disorders
Otitis externa
|
0.57%
1/176 • Number of events 1 • Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
|
1.2%
2/163 • Number of events 2 • Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
2.3%
4/176 • Number of events 4 • Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
|
4.3%
7/163 • Number of events 7 • Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
|
|
Ear and labyrinth disorders
Other
|
1.1%
2/176 • Number of events 2 • Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
|
1.2%
2/163 • Number of events 2 • Up to 1 year.
Otitis externa and cerumen impaction or ear foreign body requiring removal by a physician were considered adverse events.
|
Additional Information
Lisa Gravens-Mueller, Biostatistician/Supervisor
University of North Carolina, Chapel Hill
Phone: 919-962-3098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place