N/A
N=129
Hearing Loss Prevention for Veterans
Hearing Loss, Noise-Induced
Bottom Line
View on ClinicalTrials.gov: NCT01038336 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Percentage of Time Spent at Sound Levels >80 Decibels — 4.4; 5.0; 6.3 percentage of time — p=0.289
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multimedia Hearing Loss Prevention Program (Behavioral); Hearing Conservation Brochure (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Spent at Sound Levels >80 Decibels |
4.4; 5.0; 6.3 | 0.289 |
| SECONDARY Knowledge About Hearing Conservation Scale |
11.5; 15.0; 4.7 | 0.004 sig |
| SECONDARY Change in Perceived Susceptibility Score |
1.2; 0.4; -2.0 | 0.072 |
| SECONDARY Change in Perceived Severity Score |
7.2; 3.5; -1.7 | 0.030 sig |
| SECONDARY Change in Perceived Benefit Score |
2.6; .03; -0.8 | 0.092 |
| SECONDARY Change in Perceived Barriers Score |
1.4; 3.2; 1.1 | 0.832 |
| SECONDARY Change in Perceived Self-efficacy Score |
-.2; -1.3; 3.4 | 0.454 |
| SECONDARY Change in Cues to Action Score |
15.7; 12.8; 6.3 | 0.128 |
Summary
Hearing loss is the most prevalent service-connected disability in the VA. It causes communication difficulties, which contribute to isolation, frustration and depression. A major cause of hearing loss is from exposure to high levels of sound, and is referred to as Noise Induced Hearing Loss (NIHL). Veterans have inevitably been exposed to high levels of sound during military service, and even though they may not yet have NIHL, their ears have been damaged. Continued noise exposure in civilian life will result in NIHL. However, it can easily be prevented by avoiding noise or using hearing protection. Most people are unaware that noise damages hearing, and even when they are, they do not use hearing protection. In this study we will use a randomized controlled trial to evaluate the short- and long-term effectiveness of two forms of education about NIHL that we have developed for Veterans. One is a computerized program; the other is a Hearing Conservation Brochure
Eligibility Criteria
Inclusion Criteria
To be included in the study all participants will:
- be aged 55 years or less with no exclusions based on ethnicity or gender. The maximum age of 55 years has been selected because hearing conservation programs have the potential to be most effective for younger individuals.
- not use hearing aids
- have cognitive abilities sufficient to participate in the study, as determined by an age/and educationally appropriate score on the Mini Mental State Exam (MMSE).
- ability to read and comprehend the study interventions (HLPP and Hearing conservation brochure) as reflected by a Broad Reading Score of Grade 5 or above on the Woodcock-Johnson III Tests of Achievement Letter-Word Identification, Reading Fluency and Passage Comprehension subtests.
- no known neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review.
- adequate vision to participate in the study as determined with the Smith-Kettlewell Institute Low Luminance (SKILL) Card. Participants will be required to have best corrected vision of 20/63 (mild vision loss) or better.
- openness to using a wearable noise dosimeter and to logging daily activities using a personal digital assistant for three periods of seven days each, as determined by agreement to participate in the study.
Exclusion Criteria
Individuals will not participate in the study if:
- they are age >55 years.
- wear hearing aids
- score less than the age- and educational-based norms on the MMSE.
- have a Broad Reading score on the Woodcock-Johnson III Tests of Achievement of less than Grade 5.
- have neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study.
- have corrected vision poorer than a Snellen equivalent of 20/63.
- be unwilling to use a wearable noise dosimeter and to logging daily activities using a personal digital assistant for three periods of seven days each.
Data sourced from ClinicalTrials.gov (NCT01038336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.