Clinical trial NCT01038336: Hearing Loss Prevention for Veterans
Official title: Hearing Loss Prevention for Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Noise-Induced
Keywords: Hearing Loss - Noise-Induced
Prevention
Computer-assisted instruction
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-12-23
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed description: Hearing loss and tinnitus are the two most prevalent service-connected disabilities in the VA system for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans, and Veterans from World War II, Korea, Vietnam, the Gulf War and during Peacetime. Costs associated with health care utilization, provision of hearing aids, rehabilitation services and reduced productivity for Veterans with hearing loss are substantial, and continue to increase. On a personal level, hearing loss results in communication difficulties, and often contributes to social isolation, frustration and depression. A major cause of hearing impairment is cochlear damage from exposure to high levels of sound. The longer the period of exposure and the more intense the sound pressure level, the greater is the damage that occurs. The damage from noise exposure is cumulative over time, and exacerbates the effects of aging. Veterans, who have been exposed to high levels of sound in the military are therefore highly vulnerable to damage in civilian life, thus they must protect their ears from further noise to avoid hearing loss as they age. Unfortunately, most people are unaware of the damage noise can do to the auditory system, and even when they are aware, few choose to use hearing protection. It is therefore critical to educate Veterans about the dangers of noise exposure and the simple actions that can be taken to protect hearing.

Our long-range goal is to disseminate an effective hearing loss prevention education program that will help to reduce the prevalence and associated costs of noise induced hearing loss in the Veteran population. Ultimately it is our intention to make the program available to all Veterans, military personnel and other members of the public.

We have developed two forms of intervention to educate Veterans about hearing conservation. One is a computerized multimedia interactive program; the other is a printed Hearing Conservation Brochure. Both provide information about hearing, the damage noise can do to the auditory system, the impact hearing loss has on communication, and the use of hearing protection. In this study we will use a randomized controlled trial to evaluate the effectiveness of these two forms of intervention at changing knowledge, attitudes and behaviors toward hearing conservation. Effectiveness will be examined in three ways through assessment of: (1) actual behavioral changes, as evidenced by decreased daily noise exposure as measured with noise dosimetry; (2) reported behavioral changes, as evidenced by decreased daily noise exposure assessed using a real-time log of daily activities and use of hearing protection; and (3) increased knowledge, healthier attitudes and improved intended and actual behavior towards hearing protection, as assessed with a self-report questionnaire. Outcomes will be measured at baseline, immediately following the intervention and six month post-intervention.

There are many challenges facing military personnel as they reintegrate into society after leaving military service. Reducing their risk of acquiring noise induced hearing loss and the associated problems with communication, will help to make this transition less difficult and traumatic. This study will provide important information about the relative effectiveness of two different forms of hearing conservation education. In the long term it has the potential to reduce the prevalence and associated costs of hearing loss and tinnitus among Veterans, and will demonstrate that prevention of hearing loss can reduce the need for long-term rehabilitation.

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.

Primary outcomes:
measure: Percentage of Time Spent at Sound Levels >80 Decibels
timeFrame: 1 month
Secondary outcomes:
measure: Knowledge About Hearing Conservation Scale
timeFrame: Baseline and 1 month
measure: Change in Perceived Susceptibility Score
timeFrame: Baseline and 1 month
measure: Change in Perceived Severity Score
timeFrame: Baseline and 1 month
measure: Change in Perceived Benefit Score
timeFrame: Baseline and 1 month
measure: Change in Perceived Barriers Score
timeFrame: Baseline and 1 month
measure: Change in Perceived Self-efficacy Score
timeFrame: Baseline and 1 month
measure: Change in Cues to Action Score
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
Study officials:
affiliation: VA Medical Center, Portland
name: Gabrielle H Saunders
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saunders GH, Griest SE. Hearing loss in veterans and the need for hearing loss prevention programs. Noise Health. 2009 Jan-Mar;11(42):14-21. doi: 10.4103/1463-1741.45308.
citation: Folmer RL, Saunders GH, Dann SM, Griest SE, Porsov E, Fausti SA, Leek MR. Guest editorial: Computer-based hearing loss prevention education program for Veterans and military personnel. J Rehabil Res Dev. 2012;49(4):vii-xvi. doi: 10.1682/jrrd.2012.02.0028. No abstract available.
citation: Saunders GH, Dann SM, Griest SE, Frederick MT. Development and evaluation of a questionnaire to assess knowledge, attitudes, and behaviors towards hearing loss prevention. Int J Audiol. 2014 Apr;53(4):209-18. doi: 10.3109/14992027.2013.860487. Epub 2014 Jan 27.