NCT01038336

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.1 years

First QC Date

December 21, 2009

Results QC Date

October 21, 2014

Last Update Submit

November 19, 2014

Conditions

Hearing Loss, Noise-Induced

Keywords

Hearing Loss - Noise-InducedPreventionComputer-assisted instruction

Outcome Measures

Primary Outcomes (1)

  • Percentage of Time Spent at Sound Levels >80 Decibels

    Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels \>80 decibels

    1 month

Secondary Outcomes (7)

  • Knowledge About Hearing Conservation Scale

    Baseline and 1 month

  • Change in Perceived Susceptibility Score

    Baseline and 1 month

  • Change in Perceived Severity Score

    Baseline and 1 month

  • Change in Perceived Benefit Score

    Baseline and 1 month

  • Change in Perceived Barriers Score

    Baseline and 1 month

  • +2 more secondary outcomes

Study Arms (3)

Multimedia HLPP

EXPERIMENTAL

Multimedia Hearing Loss Prevention Program (HLPP)

Behavioral: Multimedia Hearing Loss Prevention Program

Hearing Conservation Brochure

ACTIVE COMPARATOR

Hearing Conservation Brochure (HCB)

Behavioral: Hearing Conservation Brochure

Standard-of-Care

NO INTERVENTION

Standard-of-Care (SoC)

Interventions

Multimedia Hearing Loss Prevention ProgramBEHAVIORAL

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.

Multimedia HLPP
Hearing Conservation BrochureBEHAVIORAL

Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.

Hearing Conservation Brochure

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be included in the study all participants will:
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

Related Publications (3)

  • 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.

    PMID: 19265249BACKGROUND

  • 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.

    PMID: 22773265RESULT

  • 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.

    PMID: 24467444RESULT

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gabrielle Saunders Ph.D.
Organization
VA RR&D National Center for Rehabilitative Auditory Research, Portland VA Medical Center
gabrielle.saunders@va.gov
503-220-2862

Study Officials

  • Gabrielle H Saunders

    VA Medical Center, Portland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

May 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

November 20, 2014

Results First Posted

November 20, 2014

Record last verified: 2014-11

Locations

US(1)