Noise-induced Hearing LossNCT01454895
Test of a Web-based Intervention to Promote Hearing Protector Use
A study testing Sampler of hearing protection devices, Static Web-based information and Interactive Web-based information in people with Noise-induced Hearing Loss, run by Marjorie McCullagh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise-induced Hearing Loss
- What is being tested?
- Sampler of hearing protection devices, Static Web-based information and Interactive Web-based information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- farm operators who are active in production at least half-time,
- speak English
- at least 18 years of age
- have Internet access.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Noise-induced Hearing Loss
- Being tested
- Sampler of hearing protection devices, Static Web-based information, Interactive Web-based information
- Keywords
- noise-induced hearing loss, prevention, farmers
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampler of hearing protection devicesBehavioural
Also called HPDs
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.
Static Web-based informationBehavioural
Also called SWI
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.
Interactive Web-based informationBehavioural
Also called IWI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sampler of hearing protection devices; Behavioral: 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. Receives: 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. Receives: Behavioral: Sampler of hearing protection devices; Behavioral: 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. Receives: Behavioral: Static Web-based information |
| Hearing protection Devices only | Experimental | Subjects will receive a mailed sample of various types of hearing protection devices. Receives: Behavioral: Sampler of hearing protection devices |
| Interactive Web-based information only | Other | used for cases enrolling after achievement of study enrollment goal Receives: Behavioral: Interactive Web-based information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing protector device (HPD) use
Measured: 12 months
Secondary outcomes (1)
hearing protector use-related attitudes/beliefs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Noise-induced Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marjorie McCullagh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Marjorie McCullagh, University of Michigan
- Investigators
- Marjorie C. McCullagh, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454895
- Sponsor's protocol ID
- 00027046
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2011
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26766172McCullagh 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.
PubMed 25927191
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of a Web-based Intervention to Promote Hearing Protector Use
- ClinicalTrials.gov ID
- NCT01454895
- Acronym / sponsor ID
- 00027046
- Conditions
- Noise-induced Hearing Loss
- Keywords
- noise-induced hearing loss, prevention, farmers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Marjorie McCullaghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Nov 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Interactive Web-based Info (IWI) & HPDs | Experimental | Behavioral: Sampler of hearing protection devices, Behavioral: Interactive Web-based informationSubjects 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. |
| Interactive Web-based Information (IWI) | Experimental | Behavioral: Interactive Web-based informationThis 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. |
| Static Web information (SWI) & HPDs | Experimental | Behavioral: Sampler of hearing protection devices, Behavioral: Static Web-based informationSubjects 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. |
| Static Web information only | Active comparator | Behavioral: Static Web-based informationSubjects will receive interactive Web-based information regarding farm noise exposures, risks to hearing, and strategies for protecting hearing. |
| Hearing protection Devices only | Experimental | Behavioral: Sampler of hearing protection devicesSubjects will receive a mailed sample of various types of hearing protection devices. |
| Interactive Web-based information only | Other | Behavioral: Interactive Web-based informationused for cases enrolling after achievement of study enrollment goal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- farm operators who are active in production at least half-time,
- speak English
- at least 18 years of age
- have Internet access.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampler of hearing protection devicesAlso: HPDsIn 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. | Behavioural | Hearing protection Devices only, Interactive Web-based Info (IWI) & HPDs, Static Web information (SWI) & HPDs |
| Static Web-based informationAlso: SWIThe 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. | Behavioural | Static Web information (SWI) & HPDs, Static Web information only |
| Interactive Web-based informationAlso: IWIThis 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. | Behavioural | Interactive Web-based Info (IWI) & HPDs, Interactive Web-based Information (IWI), Interactive Web-based information only |
Primary outcome
Hearing protector device (HPD) use
Time frame: 12 months
1 secondary outcome
hearing protector use-related attitudes/beliefs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Derived from this study: PubMed 26766172McCullagh 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.
- Derived from this study: PubMed 25927191McCullagh 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.
Related trials for Noise-induced Hearing Loss
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Not yet recruiting
Intervention for Hearing Health Among Native Americans
Noise-Induced Hearing Loss
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Recruiting
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Noise Exposure, Noise-induced Hearing Loss
RecruitingPhase 1/2
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Central Auditory Processing Disorder, Hearing Impaired (Partially)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie C. McCullagh, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampler of hearing protection devices, Static Web-based information and Interactive Web-based information in people with Noise-induced Hearing Loss, run by Marjorie McCullagh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing protector device (HPD) use (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.