Test of Hearing Health Education Programs for Farm and Rural Youth (FARMYOUTHEAR)
Primary Purpose
Noise-induced Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive youth educational program
Internet-based educational booster
Sponsored by
About this trial
This is an interventional prevention trial for Noise-induced Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- enrollment in grade 4
- parental consent
- English speaking
- attending a Safety Days event included in the cluster sampling
Exclusion Criteria:
- (none)
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Interactive Lesson
Interactive lesson + Web-based booster
No-intervention control
Arm Description
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health followed by an Internet-based educational booster
No interventions; pre- and post- measures only.
Outcomes
Primary Outcome Measures
Self-reported use of hearing conservation strategies (i.e., using hearing protection devices, walking away from hazardous noise, or turning down sources of hazardous noise) when in high noise
Secondary Outcome Measures
Cost effectiveness
Costs association with program delivery (i.e., instruction time, travel time)
Sustainability
Key stakeholders' ratings of program capacity to maintain program and its benefits over time using scale prepared for this purpose
Full Information
NCT ID
NCT02472821
First Posted
June 9, 2015
Last Updated
February 23, 2017
Sponsor
University of Michigan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Progressive Agriculture Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02472821
Brief Title
Test of Hearing Health Education Programs for Farm and Rural Youth
Acronym
FARMYOUTHEAR
Official Title
Test of Hearing Health Education Programs for Farm and Rural Youth
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 17, 2015 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Progressive Agriculture Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Farm and rural youth have frequent exposure to hazardous noise on the farm and recreationally, and have an increased prevalence of noise-induced hearing loss (NIHL). There is a lack of programs to prepare this high-risk population to use hearing conservation strategies. This randomly-controlled trial of innovative community-based interventions is designed to compare effectiveness and sustainability of approaches to increase youths' use of hearing conservation strategies. Consistent use of hearing conservation strategies is expected to reduce rates of NIHL and other negative effects of high noise exposure, and improve quality of life in this high-risk and underserved group.
Detailed Description
Farm and rural youth have frequent exposure to hazardous noise on the farm and recreationally, and have an increased prevalence of noise-induced hearing loss. An estimated 2 million children and adolescents younger than 20 years of age are exposed to farm noise hazards as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, or farm visitors. This noise exposure begins from an early age, and is compounded by frequent exposure to recreational noise (e.g., all-terrain vehicles and firearms). Farm youth also have an increased prevalence of noise-induced hearing loss, a permanent and irreversible condition negatively impacting quality of life of the affected person, as well as their family members.
Although primary prevention offers the best opportunity for success, farm and rural youth are rarely served by an Occupational Safety and Health Administration-mandated or other hearing conservation program. Although previous tests of limited educational programs to promote hearing conservation among small groups of farm youth have demonstrated short-term increases in hearing protector use (or intent to use), their impact on this population has been limited by program reach and sustainability.
The purpose of this project is to test innovative hearing health education programs delivered to a large target group and to determine the effectiveness and sustainability of these programs in promoting hearing health among farm and rural youth. Specifically, this project includes: a) an interactive Safety Days program alone, b) an interactive Safety Days program followed by an Internet-based booster, and c) a no-intervention control. This test is designed to determine the most effective and sustainable approach to hearing health education among farm and rural youth. Only with effective and sustainable hearing health education programs can use of hearing conservation strategies be increased to prevent noise-induced hearing loss and other negative effects of high noise exposure, and improve quality of life in this high-risk and under-served group.
This project will involve a partnership between the University of Michigan School of Nursing and a major farm and rural youth safety education organization to accomplish project aims.
This randomized-controlled trial of innovative community- based interventions is designed to determine the most effective and sustainable approach to increase youths' use of hearing protection strategies. Results of this study will be used to inform future research-to-practice studies to protect the health and safety of farm and rural youth. Consistent use of hearing conservation strategies is expected to reduce rates of noise-induced hearing loss and other negative effects of high noise exposure, and improve quality of life in this high-risk and underserved group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise-induced Hearing Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2093 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interactive Lesson
Arm Type
Active Comparator
Arm Description
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health
Arm Title
Interactive lesson + Web-based booster
Arm Type
Active Comparator
Arm Description
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health followed by an Internet-based educational booster
Arm Title
No-intervention control
Arm Type
No Intervention
Arm Description
No interventions; pre- and post- measures only.
Intervention Type
Behavioral
Intervention Name(s)
Interactive youth educational program
Other Intervention Name(s)
Progressive Agriculture Foundation Safety Days
Intervention Description
Participation in a community-based face-to-face interactive youth educational program focusing on hearing health (i.e., noise hazards, risk of noise-induced hearing loss, mechanism of injury to the internal ear, and preventive measures)
Intervention Type
Behavioral
Intervention Name(s)
Internet-based educational booster
Other Intervention Name(s)
Dangerous Decibels Virtual Exhibit
Intervention Description
Visit to an educational Web site focused on hearing health
Primary Outcome Measure Information:
Title
Self-reported use of hearing conservation strategies (i.e., using hearing protection devices, walking away from hazardous noise, or turning down sources of hazardous noise) when in high noise
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cost effectiveness
Description
Costs association with program delivery (i.e., instruction time, travel time)
Time Frame
12 months
Title
Sustainability
Description
Key stakeholders' ratings of program capacity to maintain program and its benefits over time using scale prepared for this purpose
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
enrollment in grade 4
parental consent
English speaking
attending a Safety Days event included in the cluster sampling
Exclusion Criteria:
(none)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie C McCullagh, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26475373
Citation
McCullagh MC, Banerjee T, Yang J. Protocol of a test of hearing health education programs for farm and rural youth. BMC Public Health. 2015 Oct 16;15:1061. doi: 10.1186/s12889-015-2393-y.
Results Reference
derived
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Test of Hearing Health Education Programs for Farm and Rural Youth
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