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Hearing Loss Prevention for Veterans (HLPP)

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ClinicalTrials.gov Identifier: NCT01038336
Recruitment Status : Completed
First Posted : December 23, 2009
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Hearing Loss, Noise-Induced
Interventions: Behavioral: Multimedia Hearing Loss Prevention Program
Behavioral: Hearing Conservation Brochure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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..

Participant Flow:   Overall Study
    Multimedia Hearing Loss Prevention Program   Hearing Conservation Brochure   Standard-of-Care
STARTED   43   42   44 
COMPLETED   43   42   44 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Multimedia Hearing Loss Prevention Program

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

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 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 Total of all reporting groups

Baseline Measures
   Multimedia Hearing Loss Prevention Program   Hearing Conservation Brochure   Standard-of-Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   42   44   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.8  (12.8)   37.9  (11.8)   42.2  (11.1)   38.3  (12.2) 
Gender 
[Units: Participants]
       
Female   16   18   13   47 
Male   27   24   31   82 
Knowledge about hearing conservation [1] 
[Units: Percent of correct answers]
Mean (Standard Deviation)
 57.1  (16.2)   55.1  (16.3)   56.7  (14.8)   56.3  (15.7) 
[1] 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.
Susceptibility score [1] 
[Units: Units on a scale -50 to +50]
Mean (Standard Deviation)
 26.7  (8.8)   29.2  (5.8)   30.5  (6.2)   28.8  (7.2) 
[1] Perceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. Here 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. Scores range from -50 to +50. A higher score indicates greater perceived susceptibility.
Severity score [1] 
[Units: Units on a scale -50 to +50]
Mean (Standard Deviation)
 30.0  (19.4)   33.3  (16.6)   32.8  (14.0)   32.0  (16.7) 
[1] Perceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of a condition. Here 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. Scores range from -50 to +50. A higher score indicates greater perceived severity.
Benefits score [1] 
[Units: Units on scale -50 to +50]
Mean (Standard Deviation)
 39.4  (12.7)   41.4  (9.3)   42.3  (8.7)   41.0  (10.4) 
[1] 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. Here that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire. Scores range from -50 to +50. A higher score indicates greater perceived benefit.
Barriers score [1] 
[Units: Units on a scale -50 to +50]
Mean (Standard Deviation)
 16.1  (22.7)   15.5  (24.1)   15.2  (26.2)   15.6  (24.2) 
[1] Perceived Barriers is a Health Belief Model construct defined as an individual's assessment of the influences that discourage adoption of a health behavior. Here it assesses the extent to which the individual perceives protecting hearing to be negative. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire. Scores range from -50 to +50. A higher score indicates fewer perceived barriers.
Self-efficacy score [1] 
[Units: Units on a scale -50 to +50]
Mean (Standard Deviation)
 13.7  (23.3)   9.4  (22.9)   9.6  (23.6)   10.9  (23.2) 
[1] Perceived Self-efficacy is a Health Belief Model construct defined as an individual's assessment of their ability to successfully adopt a health behavior. Here it is the extent to which the individual believes they have the capacity to their protect hearing. It was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire. Scores range from -50 to +50. A higher score indicates greater perceived self-efficacy.
Cues to action score [1] 
[Units: Units on a scale -50 to +50]
Mean (Standard Deviation)
 17.1  (28.4)   20.5  (27.7)   26.4  (24.1)   21.4  (26.9) 
[1] Cues to action is a Health Belief Model construct defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). Here it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire. Scores range from -50 to +50. A higher score indicates more cues to action.


  Outcome Measures

1.  Primary:   Percentage of Time Spent at Sound Levels >80 Decibels   [ Time Frame: 1 month ]

2.  Secondary:   Knowledge About Hearing Conservation Scale   [ Time Frame: Baseline and 1 month ]

3.  Secondary:   Change in Perceived Susceptibility Score   [ Time Frame: Baseline and 1 month ]

4.  Secondary:   Change in Perceived Severity Score   [ Time Frame: Baseline and 1 month ]

5.  Secondary:   Change in Perceived Benefit Score   [ Time Frame: Baseline and 1 month ]

6.  Secondary:   Change in Perceived Barriers Score   [ Time Frame: Baseline and 1 month ]

7.  Secondary:   Change in Perceived Self-efficacy Score   [ Time Frame: Baseline and 1 month ]

8.  Secondary:   Change in Cues to Action Score   [ Time Frame: Baseline and 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gabrielle Saunders Ph.D.
Organization: VA RR&D National Center for Rehabilitative Auditory Research, Portland VA Medical Center
phone: 503-220-2862 ext 56210
e-mail: gabrielle.saunders@va.gov


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01038336     History of Changes
Other Study ID Numbers: C7214-R
11-1408 ( Other Grant/Funding Number: VA RR&D )
02383 ( Other Identifier: Portland VAMC IRB committee )
05-2409 ( Other Identifier: Portland VAMC IRB committee )
First Submitted: December 21, 2009
First Posted: December 23, 2009
Results First Submitted: October 21, 2014
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014