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Test of a Web-based Intervention to Promote Hearing Protector Use

Primary Purpose

Noise-induced Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sampler of hearing protection devices
Static Web-based information
Interactive Web-based information
Sponsored by
Marjorie McCullagh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Noise-induced Hearing Loss focused on measuring noise-induced hearing loss, prevention, farmers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Other

Arm Label

Interactive Web-based Info (IWI) & HPDs

Interactive Web-based Information (IWI)

Static Web information (SWI) & HPDs

Static Web information only

Hearing protection Devices only

Interactive Web-based information only

Arm Description

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.

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.

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.

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

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

used for cases enrolling after achievement of study enrollment goal

Outcomes

Primary Outcome Measures

Hearing protector device (HPD) use

Secondary Outcome Measures

hearing protector use-related attitudes/beliefs

Full Information

First Posted
October 14, 2011
Last Updated
October 1, 2015
Sponsor
Marjorie McCullagh
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01454895
Brief Title
Test of a Web-based Intervention to Promote Hearing Protector Use
Official Title
Test of a Web-based Intervention to Promote Hearing Protector Use
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marjorie McCullagh
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
OBJECTIVE: To further develop and test an intervention to promote farmers' use of hearing protection devices (HPDs). SPECIFIC AIMS: The specific aim of this study is to contrast the effects of three alternative NIHL-prevention intervention strategies, delivered in various combinations on HPD use and use-related attitudes/beliefs. Specifically, the three approaches include: a) an interactive, predictors-based intervention delivered via the Internet ("Interactive Web," IWI); b) a static informational Web site designed to increase farmers' use of HPDs ("Static Web," SWI); and c) sampler of HPDs, e.g., ear muffs, plugs ("HPD Intervention," HPD I). HYPOTHESIS 1: Participants receiving interactive Web interventions (IWI) will have higher hearing protector device (HPD) use and more favorable use-related attitudes/beliefs than participants not receiving interactive web interventions (IWI); HYPOTHESIS 2: Participants receiving the HPD intervention (HPDI)will have higher HPD use and more positive use-related attitudes/beliefs than participants not receiving the HPD intervention (HPDI). HYPOTHESIS 3: Participants visiting the Web site more frequently will have higher HPD use than those visiting less frequently. HYPOTHESIS 4. There will be no interaction between intervention delivery mode (interactive vs. static) and HPDI. BACKGROUND: Farmers are among the most noise-exposed group of workers, and experience rates of noise-induced hearing loss (NIHL) of up to 72% compared to workers in other industries (x%). NIHL is associated with negative impact on quality of life, including difficulty in communication, risk of not hearing warning sounds, and tinnitus. Although use of hearing protection devices (HPDs) would protect them from NIHL, use among farmers is low. An earlier study identified predictors of use of HPDs as barriers, situational factors and gender, and accounted for 74% of the variance in use. These results also showed that a small proportion of farmers have successfully developed a variety of methods to overcome barriers and situational factors that interfere with HPD use. This project builds on the earlier work by applying these findings to develop a targeted intervention that also incorporates videotaped messages from the actual farmers who were frequent users of HPDs. METHODS: The interventions, based on the Pender Health Promotion Model, will consist of Internet-based brief interactive motivational packages regarding adopting HPD use behaviors. Outcome measures will include self-reported frequency of HPD use, measured at 6 and 12 months post-intervention. The study will involve six experimental conditions. In the first condition, farmers will receive the interactive Web intervention (IWI) and an assortment of hearing protection devices (HPDs); in the second condition, farmers will receive the interactive Web intervention (IWI) only; in the third condition, farmers will receive the static Web intervention (SWI) and HPDs; in the fourth condition, farmers will receive the static Web intervention (SWI) only; in the fifth condition, farmers will receive the assortment of HPDs only. A sixth condition will deliver the interactive Web intervention only to farmers who enroll after the target of 709 enrollees, and will receive this service as a courtesy to the American Farm Bureau and its affiliates, but cases 710 and beyond will not receive incentives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise-induced Hearing Loss
Keywords
noise-induced hearing loss, prevention, farmers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive Web-based Info (IWI) & HPDs
Arm Type
Experimental
Arm Description
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.
Arm Title
Interactive Web-based Information (IWI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Static Web information (SWI) & HPDs
Arm Type
Experimental
Arm Description
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.
Arm Title
Static Web information only
Arm Type
Active Comparator
Arm Description
Subjects will receive interactive Web-based information regarding farm noise exposures, risks to hearing, and strategies for protecting hearing.
Arm Title
Hearing protection Devices only
Arm Type
Experimental
Arm Description
Subjects will receive a mailed sample of various types of hearing protection devices.
Arm Title
Interactive Web-based information only
Arm Type
Other
Arm Description
used for cases enrolling after achievement of study enrollment goal
Intervention Type
Behavioral
Intervention Name(s)
Sampler of hearing protection devices
Other Intervention Name(s)
HPDs
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Static Web-based information
Other Intervention Name(s)
SWI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive Web-based information
Other Intervention Name(s)
IWI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hearing protector device (HPD) use
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hearing protector use-related attitudes/beliefs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: farm operators who are active in production at least half-time, speak English at least 18 years of age have Internet access.
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
26766172
Citation
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.
Results Reference
derived
PubMed Identifier
25927191
Citation
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.
Results Reference
derived

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Test of a Web-based Intervention to Promote Hearing Protector Use

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