Test of Hearing Health Education Programs for Farm and Rural Youth

Noise-induced Hearing Loss Clinical Trial

— FARMYOUTHEAR  

Official title:

Test of Hearing Health Education Programs for Farm and Rural Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472821
• Other study ID #: F037851-00
• Secondary ID: R01DC013885
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: February 23, 2017
• Start date: February 17, 2015
• Est. completion date: December 19, 2016

Study information

• Verified date: February 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2093
• Est. completion date: December 19, 2016
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• enrollment in grade 4

• parental consent

• English speaking

• attending a Safety Days event included in the cluster sampling

Exclusion Criteria:

• (none)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Noise-Induced
• Noise-induced Hearing Loss

Intervention

Behavioral:
• Interactive youth educational program
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)
• Internet-based educational booster
Visit to an educational Web site focused on hearing health

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Deafness and Other Communication Disorders (NIDCD), Progressive Agriculture Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months
Secondary	Cost effectiveness	Costs association with program delivery (i.e., instruction time, travel time)	12 months
Secondary	Sustainability	Key stakeholders' ratings of program capacity to maintain program and its benefits over time using scale prepared for this purpose	12 months