NCT01454895

Brief Summary

The purpose of this project is to compare the effectiveness of several approaches to influencing hearing protector use. The goals of this study are to further develop an intervention to promote farmers' use of hearing protectors, and compare the effectiveness of the developed intervention with two alternative approaches to influencing hearing protector use behavior, delivered in various combinations. This study will determine if significant change in hearing protection use can be achieved in a one-shot web-based or protector-supply intervention. Results will determine the need for future program modifications, e.g., inclusion of booster(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

October 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

October 14, 2011

Last Update Submit

October 1, 2015

Conditions

Keywords

noise-induced hearing losspreventionfarmers

Outcome Measures

Primary Outcomes (1)

  • Hearing protector device (HPD) use

    12 months

Secondary Outcomes (1)

  • hearing protector use-related attitudes/beliefs

    12 months

Study Arms (6)

Interactive Web-based Info (IWI) & HPDs

EXPERIMENTAL

Subjects will receive interactive Web-based information regarding farm noise exposures, risks to hearing, and strategies for protecting hearing, as well as a mailed sample of various types of hearing protection devices.

Behavioral: Sampler of hearing protection devicesBehavioral: Interactive Web-based information

Interactive Web-based Information (IWI)

EXPERIMENTAL

This intervention includes a number of features/techniques designed to promote behavior change. Messages focus on farmer-friendly techniques for adopting use of HPDs. The factors found to be significant predictors of HPD use (Barriers to Use and Situational Factors Influencing HPD Use) are particularly relevant to farmers' learning needs, and are especially emphasized in this model-based intervention to increase hearing protector use among farmers. Participants will select the sequence of features they visit, as well as the time spent in each feature and number of visits to the site. Their patterns of use will be tracked by the enrollment and data collection systems and used in analysis.

Behavioral: Interactive Web-based information

Static Web information (SWI) & HPDs

EXPERIMENTAL

Subjects will receive static Web-based information regarding farm noise exposures, risks to hearing, and strategies for protecting hearing, as well as a mailed sample of various types of hearing protection devices.

Behavioral: Sampler of hearing protection devicesBehavioral: Static Web-based information

Static Web information only

ACTIVE COMPARATOR

Subjects will receive interactive Web-based information regarding farm noise exposures, risks to hearing, and strategies for protecting hearing.

Behavioral: Static Web-based information

Hearing protection Devices only

EXPERIMENTAL

Subjects will receive a mailed sample of various types of hearing protection devices.

Behavioral: Sampler of hearing protection devices

Interactive Web-based information only

OTHER

used for cases enrolling after achievement of study enrollment goal

Behavioral: Interactive Web-based information

Interventions

In a pilot study, hearing protection devices were mailed to farmers, resulting in a significant increase in use. These results suggested that overall, HPDs were acceptable to farmers, and that access to HPDs may be an important contributor to frequency of use. The study will build on this earlier work by providing an assortment of hearing protection devices to a sub-sample of each group of farmers receiving the Interactive and Static Web Interventions. The assortment includes the most commonly used types of devices (i.e., muffs, foam plugs, pre-molded plugs, and semi-aurals). The sampler is delivered, together with manufacturers' standard written instructions for use, via mail at the designated time according study design.

Also known as: HPDs
Hearing protection Devices onlyInteractive Web-based Info (IWI) & HPDsStatic Web information (SWI) & HPDs

The standard information promoting HPD use delivered via Internet will be based on an informational brochure previously developed for use by farmers (i.e., Have You Heard? and They're Your Ears Protect Them). These brochures, including color graphics and text, are available on the Internet (as PDF files). Although they have been printed and distributed by NIOSH, most farmers will not have been exposed to copies. There are important differences between the SWI and IWI interventions, including interactivity, animation, explication of farmer-generated tips and techniques for addressing common barriers to hearing protector use, use of color, audio, and video, hotlinks, and farmer testimonials.

Also known as: SWI
Static Web information (SWI) & HPDsStatic Web information only

This intervention includes a number of features/techniques designed to promote behavior change. Messages focus on farmer-friendly techniques for adopting use of HPDs. The factors found to be significant predictors of HPD use (Barriers to Use and Situational Factors Influencing HPD Use) are particularly relevant to farmers' learning needs, and are especially emphasized in this model-based intervention to increase hearing protector use among farmers. Participants will select the sequence of features they visit, as well as the time spent in each feature and number of visits to the site. Their patterns of use will be tracked by the enrollment and data collection systems and used in analysis.

Also known as: IWI
Interactive Web-based Info (IWI) & HPDsInteractive Web-based Information (IWI)Interactive Web-based information only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • farm operators who are active in production at least half-time,
  • speak English
  • at least 18 years of age
  • have Internet access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • McCullagh MC, Banerjee T, Cohen MA, Yang JJ. Effects of interventions on use of hearing protectors among farm operators: A randomized controlled trial. Int J Audiol. 2016;55 Suppl 1(0):S3-12. doi: 10.3109/14992027.2015.1122239. Epub 2016 Jan 14.

  • McCullagh MC, Ronis DL. Protocol of a randomized controlled trial of hearing protection interventions for farm operators. BMC Public Health. 2015 Apr 18;15:399. doi: 10.1186/s12889-015-1743-0.

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

Study Officials

  • Marjorie C. McCullagh, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 19, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations