Trial Outcomes & Findings for A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes (NCT NCT01940705)
NCT ID: NCT01940705
Last Updated: 2019-02-21
Results Overview
Hearing Aid Skills and Knowledge measures knowledge and skills for tasks associated with hearing aid management, such as knowledge of and ability to change batteries, insert the hearing aid, etc. For knowledge scale, participant gives a verbal response. Items are assigned points: 0 (incorrect response) or 1 (correct response). For skills scale, participant conducts the required task. Items are assigned points: 0 (Could not perform task), 1 (Achieved with some difficulty, more than one attempt) or 2 (Achieved with no difficulty on first attempt). There were 15 knowledge items and 19 skill items. Percent correct was computed for each scale separately. Points were totaled, divided by the no. items with valid data, and multiplied by 100, with a correction to equate subscales. For the skills scale, percent correct scores were calculated based upon the notion that a value of 2 was considered 100% correct, 1 was considered 50% correct.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
269 participants
Primary outcome timeframe
4 weeks after the hearing-aid fitting
Results posted on
2019-02-21
Participant Flow
Participant milestones
| Measure |
Standard of Care
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Hearing-aid Informational Guide
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus a Take-home Digital Video Disc
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home digital video disc regarding hearing aids
Hearing-Aid digital video disc : Take-home digital video disc about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Counseling With the Teach-back Technique
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
69
|
67
|
|
Overall Study
COMPLETED
|
62
|
59
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
8
|
4
|
Reasons for withdrawal
| Measure |
Standard of Care
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Hearing-aid Informational Guide
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus a Take-home Digital Video Disc
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home digital video disc regarding hearing aids
Hearing-Aid digital video disc : Take-home digital video disc about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Counseling With the Teach-back Technique
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
2
|
|
Overall Study
Intervention not given
|
0
|
3
|
3
|
0
|
|
Overall Study
Withdrawal by team - hearing aid change
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Simplified Patient-Centered Educational Tool for Improved Hearing-Aid Outcomes
Baseline characteristics by cohort
| Measure |
Standard of Care
n=66 Participants
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
SoC Plus Hearing-aid Informational Guide
n=67 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
SoC Plus a Take-home DVD
n=69 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
Hearing-Aid DVD: Take-home DVD about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
SoC Plus Counseling With the Teach-back Technique
n=67 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
69.2 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
264 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
67 participants
n=7 Participants
|
69 participants
n=5 Participants
|
67 participants
n=4 Participants
|
269 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the hearing-aid fittingHearing Aid Skills and Knowledge measures knowledge and skills for tasks associated with hearing aid management, such as knowledge of and ability to change batteries, insert the hearing aid, etc. For knowledge scale, participant gives a verbal response. Items are assigned points: 0 (incorrect response) or 1 (correct response). For skills scale, participant conducts the required task. Items are assigned points: 0 (Could not perform task), 1 (Achieved with some difficulty, more than one attempt) or 2 (Achieved with no difficulty on first attempt). There were 15 knowledge items and 19 skill items. Percent correct was computed for each scale separately. Points were totaled, divided by the no. items with valid data, and multiplied by 100, with a correction to equate subscales. For the skills scale, percent correct scores were calculated based upon the notion that a value of 2 was considered 100% correct, 1 was considered 50% correct.
Outcome measures
| Measure |
Standard of Care
n=62 Participants
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Hearing-aid Informational Guide
n=59 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus a Take-home Digital Video Disc
n=61 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
Hearing-Aid digital video disc: Take-home digital video disc about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Counseling With the Teach-back Technique
n=63 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
|---|---|---|---|---|
|
Hearing Aid Skills and Knowledge Test
Hearing Aid Skills and Knowledge Test Knowledge
|
65.4 percentage of correct responses
Standard Deviation 12.2
|
68.3 percentage of correct responses
Standard Deviation 12.3
|
66.2 percentage of correct responses
Standard Deviation 11.8
|
74.6 percentage of correct responses
Standard Deviation 12.3
|
|
Hearing Aid Skills and Knowledge Test
Hearing Aid Skills and Knowledge Test Skill
|
77.3 percentage of correct responses
Standard Deviation 11.2
|
80.3 percentage of correct responses
Standard Deviation 10.7
|
78.9 percentage of correct responses
Standard Deviation 9.4
|
83.0 percentage of correct responses
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 4 weeks after the hearing-aid fittingPopulation: Questionnaire data are missing due to a technical issue for one individual in the SoC plus hearing-aid informational guide arm and one in the SoC plus counseling with the teach-back technique
12-item questionnaire assessing self-efficacy for basic and advanced hearing aid handling skills. Item responses are on a scale of 0 to 100 in 10 point increments. Score of 0 = no self efficacy to100 = complete self efficacy. Final score is an average of individual item responses.
Outcome measures
| Measure |
Standard of Care
n=62 Participants
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Hearing-aid Informational Guide
n=58 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus a Take-home Digital Video Disc
n=61 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
Hearing-Aid digital video disc: Take-home digital video disc about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Counseling With the Teach-back Technique
n=62 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
|---|---|---|---|---|
|
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids
|
77.1 units on a scale
Standard Deviation 15.3
|
78.4 units on a scale
Standard Deviation 11.5
|
80.1 units on a scale
Standard Deviation 12.4
|
80.9 units on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 4 weeks after the hearing-aid fittingPopulation: Questionnaire data are missing for one individual in the Standard of care arm, five in the SoC plus hearing-aid informational guide arm, five in the Standard of care plus a take-home digital video disc and two in the SoC plus counseling with the teach-back technique due to technical issues.
Hearing-aid outcomes questionnaire assessing benefit, satisfaction, use, etc. Seven items, each on a scale of 1-5. 1 = low satisfaction/benefit/use etc., 5 = maximum satisfaction/benefit/use etc. A total score is derived by summing the score from each of the seven items. Total scores range from a low of 7 to a high of 35.
Outcome measures
| Measure |
Standard of Care
n=61 Participants
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Hearing-aid Informational Guide
n=54 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus a Take-home Digital Video Disc
n=56 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
Hearing-Aid digital video disc: Take-home digital video disc about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
Standard of Care Plus Counseling With the Teach-back Technique
n=61 Participants
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
|---|---|---|---|---|
|
International Outcome Inventory for Hearing Aids.
|
29.3 units on a scale
Standard Deviation 4.2
|
29.7 units on a scale
Standard Deviation 4.5
|
29.7 units on a scale
Standard Deviation 4.1
|
30.0 units on a scale
Standard Deviation 4.0
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SoC Plus Hearing-aid Informational Guide
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
SoC Plus a Take-home DVD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SoC Plus Counseling With the Teach-back Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=62 participants at risk
standard of care hearing-aid orientation as provided by clinical audiologist
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
SoC Plus Hearing-aid Informational Guide
n=59 participants at risk
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home informational guide regarding their hearing aids
Hearing-Aid Informational Guide: Printed take-home guide on hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
SoC Plus a Take-home DVD
n=61 participants at risk
standard of care hearing-aid orientation as provided by clinical audiologist plus a take-home DVD regarding hearing aids
Hearing-Aid DVD: Take-home DVD about hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
SoC Plus Counseling With the Teach-back Technique
n=63 participants at risk
standard of care hearing-aid orientation as provided by clinical audiologist plus a teach-back technique counseling session reviewing information on the hearing aids
Teach-back Technique: Counseling/Educational session using the teach-back technique to review information about their hearing aids
Standard of Care: standard of care hearing-aid orientation as provided by clinical audiologist
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Non-study-related adverse event
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/61
|
0.00%
0/63
|
Other adverse events
Adverse event data not reported
Additional Information
Gabrielle Saunders, PhD
VA RR&D National Center for Rehabilitative Auditory Research
Phone: 503-220-8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place