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Hearing Loss Prevention for Veterans (HLPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01038336
First received: December 21, 2009
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention
Hearing Loss, Noise-Induced
Behavioral: Multimedia Hearing Loss Prevention Program
Behavioral: Hearing Conservation Brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Hearing Loss Prevention for Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Percentage of Time Spent at Sound Levels >80 Decibels [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels


Secondary Outcome Measures:
  • Knowledge About Hearing Conservation Scale [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Knowledge 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.

  • Change in Perceived Susceptibility Score [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Perceived 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.

  • Change in Perceived Severity Score [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Perceived 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.

  • Change in Perceived Benefit Score [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Perceived 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.

  • Change in Perceived Barriers Score [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Perceived 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.

  • Change in Perceived Self-efficacy Score [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Perceived 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.

  • Change in Cues to Action Score [ Time Frame: Baseline and 1 month ] [ Designated as safety issue: No ]
    Cues 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.


Enrollment: 129
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multimedia HLPP
Multimedia Hearing Loss Prevention Program (HLPP)
Behavioral: Multimedia Hearing Loss Prevention Program
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.
Active Comparator: Hearing Conservation Brochure
Hearing Conservation Brochure (HCB)
Behavioral: Hearing Conservation Brochure
Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
No Intervention: Standard-of-Care
Standard-of-Care (SoC)

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038336

Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Investigators
Principal Investigator: Gabrielle H Saunders VA Medical Center, Portland
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01038336     History of Changes
Other Study ID Numbers: C7214-R, 11-1408, 02383, 05-2409
Study First Received: December 21, 2009
Results First Received: October 21, 2014
Last Updated: November 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hearing Loss - Noise-Induced
Prevention
Computer-assisted instruction

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Noise-Induced
Ear Diseases
Hearing Disorders
Hearing Loss, Sensorineural
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014