Trial Outcomes & Findings for Hearing Loss Prevention for Veterans (NCT NCT01038336)
NCT ID: NCT01038336
Last Updated: 2014-11-20
Results Overview
Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels \>80 decibels
COMPLETED
NA
129 participants
1 month
2014-11-20
Participant Flow
Participant milestones
| Measure |
Multimedia Hearing Loss Prevention Program
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
Hearing Conservation Brochure (HCB)
The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
44
|
|
Overall Study
COMPLETED
|
43
|
42
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hearing Loss Prevention for Veterans
Baseline characteristics by cohort
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP)
The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
Hearing Conservation brochure: The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Knowledge about hearing conservation
|
57.1 percent of correct answers
STANDARD_DEVIATION 16.2 • n=5 Participants
|
55.1 percent of correct answers
STANDARD_DEVIATION 16.3 • n=7 Participants
|
56.7 percent of correct answers
STANDARD_DEVIATION 14.8 • n=5 Participants
|
56.3 percent of correct answers
STANDARD_DEVIATION 15.7 • n=4 Participants
|
|
Susceptibility score
|
26.7 units on a scale -50 to +50
STANDARD_DEVIATION 8.8 • n=5 Participants
|
29.2 units on a scale -50 to +50
STANDARD_DEVIATION 5.8 • n=7 Participants
|
30.5 units on a scale -50 to +50
STANDARD_DEVIATION 6.2 • n=5 Participants
|
28.8 units on a scale -50 to +50
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Severity score
|
30.0 units on a scale -50 to +50
STANDARD_DEVIATION 19.4 • n=5 Participants
|
33.3 units on a scale -50 to +50
STANDARD_DEVIATION 16.6 • n=7 Participants
|
32.8 units on a scale -50 to +50
STANDARD_DEVIATION 14.0 • n=5 Participants
|
32.0 units on a scale -50 to +50
STANDARD_DEVIATION 16.7 • n=4 Participants
|
|
Benefits score
|
39.4 Units on scale -50 to +50
STANDARD_DEVIATION 12.7 • n=5 Participants
|
41.4 Units on scale -50 to +50
STANDARD_DEVIATION 9.3 • n=7 Participants
|
42.3 Units on scale -50 to +50
STANDARD_DEVIATION 8.7 • n=5 Participants
|
41.0 Units on scale -50 to +50
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Barriers score
|
16.1 Units on a scale -50 to +50
STANDARD_DEVIATION 22.7 • n=5 Participants
|
15.5 Units on a scale -50 to +50
STANDARD_DEVIATION 24.1 • n=7 Participants
|
15.2 Units on a scale -50 to +50
STANDARD_DEVIATION 26.2 • n=5 Participants
|
15.6 Units on a scale -50 to +50
STANDARD_DEVIATION 24.2 • n=4 Participants
|
|
Self-efficacy score
|
13.7 Units on a scale -50 to +50
STANDARD_DEVIATION 23.3 • n=5 Participants
|
9.4 Units on a scale -50 to +50
STANDARD_DEVIATION 22.9 • n=7 Participants
|
9.6 Units on a scale -50 to +50
STANDARD_DEVIATION 23.6 • n=5 Participants
|
10.9 Units on a scale -50 to +50
STANDARD_DEVIATION 23.2 • n=4 Participants
|
|
Cues to action score
|
17.1 Units on a scale -50 to +50
STANDARD_DEVIATION 28.4 • n=5 Participants
|
20.5 Units on a scale -50 to +50
STANDARD_DEVIATION 27.7 • n=7 Participants
|
26.4 Units on a scale -50 to +50
STANDARD_DEVIATION 24.1 • n=5 Participants
|
21.4 Units on a scale -50 to +50
STANDARD_DEVIATION 26.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 monthObjective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels \>80 decibels
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Percentage of Time Spent at Sound Levels >80 Decibels
|
4.4 percentage of time
Standard Deviation 0.05
|
5.0 percentage of time
Standard Deviation 0.05
|
6.3 percentage of time
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline and 1 monthKnowledge about hearing conservation was assessed with 16 items in the the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). It is a validated questionnaire that assesses knowledge about and attitudes toward hearing and hearing loss prevention. The Knowledge scale is scored as a percent correct, with a higher score indicating more knowledge. Data presented are for change in knowledge between baseline and 1-month follow-up computed such that a higher score indicates greater increase in knowledge.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Knowledge About Hearing Conservation Scale
|
11.5 percent of correct answers
Standard Deviation 16.6
|
15.0 percent of correct answers
Standard Deviation 14.1
|
4.7 percent of correct answers
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPerceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. In the current study it assesses the extent to which the individual feels vulnerable to hearing loss. Perceived Susceptibility was assessed with 5 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived susceptibility, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Susceptibility was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived susceptibility at follow-up.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Change in Perceived Susceptibility Score
|
1.2 Units on a scale
Standard Deviation 7.9
|
0.4 Units on a scale
Standard Deviation 5.6
|
-2.0 Units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPerceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of the consequences of a condition if it is acquired. In the current study it assesses the extent to which the individual believes that a hearing loss would have negative consequences. Perceived Severity was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived severity, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Severity was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived severity at follow-up.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Change in Perceived Severity Score
|
7.2 Units on a scale
Standard Deviation 17.2
|
3.5 Units on a scale
Standard Deviation 13.5
|
-1.7 Units on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPerceived Benefit is a construct from the Health Belief Model defined as an individual's assessment of the positive consequences of adopting a health behavior. In the present study that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived benefit, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived benefit was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived benefit at follow-up.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Change in Perceived Benefit Score
|
2.6 units on scale
Standard Deviation 5.7
|
.03 units on scale
Standard Deviation 8.0
|
-0.8 units on scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPerceived Barriers is a construct from the Health Belief Model defined as an individual's assessment of the influences that discourage adoption of a health behavior. In the current study it assesses the extent to which the individual perceives few negative influences to protecting hearing. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating fewer perceived barriers, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Barriers was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating fewer perceived barriers at follow-up.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Change in Perceived Barriers Score
|
1.4 Units on a scale
Standard Deviation 14.2
|
3.2 Units on a scale
Standard Deviation 20.7
|
1.1 Units on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPerceived Self-efficacy is a construct from the Health Belief Model defined as an individual's assessment of his/her ability to successfully adopt a health behavior. In the current study it assesses the extent to which the individual believes that he/she has the knowledge and abilities to protect hearing. Perceived Self-efficacy was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived self-efficacy, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Self-efficacy was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived self-efficacy at follow-up.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Change in Perceived Self-efficacy Score
|
-.2 Units on a scale
Standard Deviation 18.0
|
-1.3 Units on a scale
Standard Deviation 15.3
|
3.4 Units on a scale
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: Baseline and 1 monthCues to action is a construct from the Health Belief Model defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). In the current study it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater cues to action, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Cues to action was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating more Cues to action having been received at follow-up.
Outcome measures
| Measure |
Multimedia Hearing Loss Prevention Program
n=43 Participants
Multimedia Hearing Loss Prevention Program (HLPP):
Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
|
Hearing Conservation Brochure
n=42 Participants
Hearing Conservation Brochure (HCB)
The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
|
Standard-of-Care
n=44 Participants
Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
|
|---|---|---|---|
|
Change in Cues to Action Score
|
15.7 Units on a scale
Standard Deviation 24.7
|
12.8 Units on a scale
Standard Deviation 22.0
|
6.3 Units on a scale
Standard Deviation 19.3
|
Adverse Events
Multimedia Hearing Loss Prevention Program
Hearing Conservation Brochure
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gabrielle Saunders Ph.D.
VA RR&D National Center for Rehabilitative Auditory Research, Portland VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place