Work Related Musculoskeletal DisordersSAVENCT02676635
Safety Voice for Ergonomics as a Preventive Approach for Work-related Musculoskeletal Disorders in Masonry Apprentices
A study testing Ergonomics training and/or Safety Voice training in people with Work Related Musculoskeletal Disorders, run by Eastern Washington University at 1 site in United States.
Trial summary
Masons have the highest rate of overexertion injuries among all construction trades and rank second as an occupation for back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work Related Musculoskeletal Disorders
- What is being tested?
- Ergonomics training and/or Safety Voice training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Aug 2019
- 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
- Currently employed masonry apprentices in their first two years of training and at least 18 years of age will be recruited to participate and provide signed informed consent. No potential participant will be excluded because of co-morbid medical conditions.
Who cannot join
- Apprentices who do not have reliable access to a computer or who do not use a cell phone will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Washington University
Spokane, Washington, 99202
About this study
Official title: National Center for Construction Safety and Health Research and Translation: Safety Voice for Ergonomics
Masons have the highest rate of overexertion injuries among all construction trades and rank second as an occupation for back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on their careers, are greatly in need of ergonomics training to minimize the cumulative exposure that leads to musculoskeletal disorders. Apprentices receive safety training; however, ergonomics training is often limited or non-existent. In addition, apprenticeship programs often lack "soft skills" training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to integrate evidence-based health and safety training strategies into the mason apprenticeship skills training to teach ergonomics, problem solving, and speaking up to communicate solutions that reduce musculoskeletal injury risk. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone.
Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated in a cluster-randomized controlled trial at 12-15 masonry training centers across the U.S. Clusters of apprentices within centers will be assigned at random to one of three intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics and safety voice training, or (3) control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months post training will include: musculoskeletal symptoms, general health perceptions, knowledge of ergonomic and safety voice principles, and perception and attitudes about ergonomic and safety voice issues.
Read the detailed description
- Rationale Masons have the highest rate of overexertion injuries among all construction trades and rank second as an occupation for back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices have the greatest need for ergonomics training as they embark on their careers to minimize cumulative exposure that leads to musculoskeletal disorders. Additionally, apprenticeship training programs often lack "soft skills" training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to integrate evidence-based health and safety training strategies into current masonry apprenticeship skills training to teach ergonomics, problem solving, and speaking up to reduce musculoskeletal injury risk. SAVE will incorporate blended learning principles by combining traditional, face-to-face teaching methods with e-learning methods.
- Objectives The primary objective of this project is to evaluate the SAVE program in a cluster randomized controlled trial in 12-15 masonry training centers. Clusters of apprentices within centers will be assigned at random to one of four intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics and safety voice training, or (3) control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at 6 and 12 months post training will include: musculoskeletal symptoms, general health perceptions, knowledge of ergonomic and safety voice principles, and perception and attitudes about ergonomic and safety voice issues. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone.
- Procedures Primary Training Program E-learning Modules. Depending on the group to which a training center is assigned, apprentices within that center will view brief e-learning training modules to provide apprentices with basic knowledge of ergonomic and/or safety voice principles. These modules include text, brief video clips, and interactive on-screen slides that guide apprentices through content with brief quizzes that assure understanding. Apprentices will complete the modules at the apprenticeship training center. Learning gained from completing the e-learning modules will be reinforced by short (10-20 minute), applied, face-to-face experiential activities. These interactive, face-to-face, problem-solving activities will complement the e-learning and will include vignettes to promote discussion of hypothetical worksite cases related to ergonomics and/or safety voice. These vignettes will be brief to fit into existing training time demands.
Secondary (Refresher) Training Program Refresher training for ergonomics and/or safety voice will bolster concepts learned by apprentices in the primary training. Depending on the group to which a training center is assigned, apprentices within that center will receive refresher training through text messages that are sent by the researchers. Secondary training is considered medium engagement learning since apprentices will respond to texts. For example, an ergonomic-related text message would read, "Keeping work between knee and shoulder level reduces the risk of a back or shoulder injury. During the past week have you worked on adjustable scaffolding?" The apprentice will respond "Yes" or "No." Apprentices responding "Yes" will receive a follow-up text/email reminding them of the importance of keeping work between knee and shoulder level. Refresher training will be delivered over a one-year period to maximize knowledge retention.
- Conditions
- Work Related Musculoskeletal Disorders
- Being tested
- Ergonomics training and/or Safety Voice training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomics training and/or Safety Voice trainingBehavioural
Ergonomics training will focus on ergonomic principles specific to masonry such as goals of ergonomics, common musculoskeletal disorders among masons, modifiable work factors and risk factors, hazard analysis, hierarchy of controls, and current ergonomic solutions for masonry. Safety Voice training will focus on development of skills such as self-direction, self-control, accountability, responsibility, communication strategies, and leadership that can help them to develop a "safety voice" about safety in general, and ergonomics specifically.
| Study group | Role | What they receive |
|---|---|---|
| Ergonomics Training Only | Experimental | Participants in this arm receive Ergonomics training only Receives: Behavioral: Ergonomics training and/or Safety Voice training |
| Ergonomics and Safety Voice Training | Experimental | Participants in this arm receive training on both Ergonomic principles and Safety Voice training Receives: Behavioral: Ergonomics training and/or Safety Voice training |
| Control Group | No intervention | Participants in this arm will receive no additional Ergonomics or Safety Voice training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Nordic Questionnaire
The Modified Nordic Questionnaire assesses self-reported musculoskeletal symptoms. The questionnaire requires a "yes" or "no" response to three questions for nine different anatomic sites: "During the last 12 months have you had a job-related ache, pain, discomfort"; "During the last 12 months have you been prevented from doing your day's work due to this condition?" and "During the last 12 months have you seen a physician for this condition?"
Measured: Change from baseline through study completion, an average of 1 year
Short Form-36 Health Survey (SF-36v2®)
The Short Form-36 Health Survey (SF-36v2®) is a standardized health questionnaire of perceived physical and mental health status, which has been shown to be associated with occupational safety and health behavior change.
Measured: Change from baseline through study completion, an average of 1 year
SAVE Reaction
To measure the reaction of the apprentices to the SAVE training, four, standard, 5-point scale questions will be used (1 = strongly disagree to 5 =strongly agree).
Measured: Change from baseline through study completion, an average of 1 year
SAVE Knowledge Acquisition
These questions will assess knowledge gained of ergonomic and safety voice principles covered in the SAVE program.
Measured: Change from baseline through study completion, an average of 1 year
SAVE Attitude, Compliance, and Participation
These questions will evaluate apprentice attitudes and perception about ergonomic and safety voice issues using a 5-point scale (strongly disagree to strongly agree).
Measured: Change from baseline through study completion, an average of 1 year
SAVE Adoption
These questions will provide information about whether apprentices used interventions more frequently, or were more willing to adopt new ergonomic interventions when appropriate.
Measured: Change from baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work Related Musculoskeletal DisordersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon State University, University of Oregon, St. Luke's Rehabilitation Institute
- Responsible party
- Principal investigator, Daniel Anton, Eastern Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676635
- Sponsor's protocol ID
- 2U60OH009762-06
- Acronym
- SAVE
- Status last verified
- Sep 2018
- First submitted
- 28 Jan 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kincl LD, Anton D, Hess JA, Weeks DL. Safety voice for ergonomics (SAVE) project: protocol for a workplace cluster-randomized controlled trial to reduce musculoskeletal disorders in masonry apprentices. BMC Public Health. 2016 Apr 27;16:362. doi: 10.1186/s12889-016-2989-x.
PubMed 27121123
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Center for Construction Safety and Health Research and Translation: Safety Voice for Ergonomics
- ClinicalTrials.gov ID
- NCT02676635
- Acronym / sponsor ID
- SAVE / 2U60OH009762-06
- Conditions
- Work Related Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Eastern Washington UniversityUniversity, hospital or other
- Collaborators
- Oregon State University, University of Oregon, St. Luke's Rehabilitation Institute
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 8 Feb 2016 (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.
Masons have the highest rate of overexertion injuries among all construction trades and rank second as an occupation for back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on their careers, are greatly in need of ergonomics training to minimize the cumulative exposure that leads to musculoskeletal disorders. Apprentices receive safety training; however, ergonomics training is often limited or non-existent. In addition, apprenticeship programs often lack "soft skills" training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to integrate evidence-based health and safety training strategies into the mason apprenticeship skills training to teach ergonomics, problem solving, and speaking up to communicate solutions that reduce musculoskeletal injury risk. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone.
Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated in a cluster-randomized controlled trial at 12-15 masonry training centers across the U.S. Clusters of apprentices within centers will be assigned at random to one of three intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics and safety voice training, or (3) control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months post training will include: musculoskeletal symptoms, general health perceptions, knowledge of ergonomic and safety voice principles, and perception and attitudes about ergonomic and safety voice issues.
Detailed description
- Rationale Masons have the highest rate of overexertion injuries among all construction trades and rank second as an occupation for back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices have the greatest need for ergonomics training as they embark on their careers to minimize cumulative exposure that leads to musculoskeletal disorders. Additionally, apprenticeship training programs often lack "soft skills" training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to integrate evidence-based health and safety training strategies into current masonry apprenticeship skills training to teach ergonomics, problem solving, and speaking up to reduce musculoskeletal injury risk. SAVE will incorporate blended learning principles by combining traditional, face-to-face teaching methods with e-learning methods.
- Objectives The primary objective of this project is to evaluate the SAVE program in a cluster randomized controlled trial in 12-15 masonry training centers. Clusters of apprentices within centers will be assigned at random to one of four intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics and safety voice training, or (3) control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at 6 and 12 months post training will include: musculoskeletal symptoms, general health perceptions, knowledge of ergonomic and safety voice principles, and perception and attitudes about ergonomic and safety voice issues. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone.
- Procedures Primary Training Program E-learning Modules. Depending on the group to which a training center is assigned, apprentices within that center will view brief e-learning training modules to provide apprentices with basic knowledge of ergonomic and/or safety voice principles. These modules include text, brief video clips, and interactive on-screen slides that guide apprentices through content with brief quizzes that assure understanding. Apprentices will complete the modules at the apprenticeship training center. Learning gained from completing the e-learning modules will be reinforced by short (10-20 minute), applied, face-to-face experiential activities. These interactive, face-to-face, problem-solving activities will complement the e-learning and will include vignettes to promote discussion of hypothetical worksite cases related to ergonomics and/or safety voice. These vignettes will be brief to fit into existing training time demands.
Secondary (Refresher) Training Program Refresher training for ergonomics and/or safety voice will bolster concepts learned by apprentices in the primary training. Depending on the group to which a training center is assigned, apprentices within that center will receive refresher training through text messages that are sent by the researchers. Secondary training is considered medium engagement learning since apprentices will respond to texts. For example, an ergonomic-related text message would read, "Keeping work between knee and shoulder level reduces the risk of a back or shoulder injury. During the past week have you worked on adjustable scaffolding?" The apprentice will respond "Yes" or "No." Apprentices responding "Yes" will receive a follow-up text/email reminding them of the importance of keeping work between knee and shoulder level. Refresher training will be delivered over a one-year period to maximize knowledge retention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ergonomics Training Only | Experimental | Behavioral: Ergonomics training and/or Safety Voice trainingParticipants in this arm receive Ergonomics training only |
| Ergonomics and Safety Voice Training | Experimental | Behavioral: Ergonomics training and/or Safety Voice trainingParticipants in this arm receive training on both Ergonomic principles and Safety Voice training |
| Control Group | No intervention | –Participants in this arm will receive no additional Ergonomics or Safety Voice training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently employed masonry apprentices in their first two years of training and at least 18 years of age will be recruited to participate and provide signed informed consent. No potential participant will be excluded because of co-morbid medical conditions.
Key exclusion criteria (1 listed)
- Apprentices who do not have reliable access to a computer or who do not use a cell phone will be excluded from participation.
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 |
|---|---|---|
| Ergonomics training and/or Safety Voice trainingErgonomics training will focus on ergonomic principles specific to masonry such as goals of ergonomics, common musculoskeletal disorders among masons, modifiable work factors and risk factors, hazard analysis, hierarchy of controls, and current ergonomic solutions for masonry. Safety Voice training will focus on development of skills such as self-direction, self-control, accountability, responsibility, communication strategies, and leadership that can help them to develop a "safety voice" about safety in general, and ergonomics specifically. | Behavioural | Ergonomics Training Only, Ergonomics and Safety Voice Training |
Primary outcome
Modified Nordic Questionnaire
Time frame: Change from baseline through study completion, an average of 1 year
The Modified Nordic Questionnaire assesses self-reported musculoskeletal symptoms. The questionnaire requires a "yes" or "no" response to three questions for nine different anatomic sites: "During the last 12 months have you had a job-related ache, pain, discomfort"; "During the last 12 months have you been prevented from doing your day's work due to this condition?" and "During the last 12 months have you seen a physician for this condition?"
Short Form-36 Health Survey (SF-36v2®)
Time frame: Change from baseline through study completion, an average of 1 year
The Short Form-36 Health Survey (SF-36v2®) is a standardized health questionnaire of perceived physical and mental health status, which has been shown to be associated with occupational safety and health behavior change.
SAVE Reaction
Time frame: Change from baseline through study completion, an average of 1 year
To measure the reaction of the apprentices to the SAVE training, four, standard, 5-point scale questions will be used (1 = strongly disagree to 5 =strongly agree).
SAVE Knowledge Acquisition
Time frame: Change from baseline through study completion, an average of 1 year
These questions will assess knowledge gained of ergonomic and safety voice principles covered in the SAVE program.
SAVE Attitude, Compliance, and Participation
Time frame: Change from baseline through study completion, an average of 1 year
These questions will evaluate apprentice attitudes and perception about ergonomic and safety voice issues using a 5-point scale (strongly disagree to strongly agree).
SAVE Adoption
Time frame: Change from baseline through study completion, an average of 1 year
These questions will provide information about whether apprentices used interventions more frequently, or were more willing to adopt new ergonomic interventions when appropriate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 27121123Kincl LD, Anton D, Hess JA, Weeks DL. Safety voice for ergonomics (SAVE) project: protocol for a workplace cluster-randomized controlled trial to reduce musculoskeletal disorders in masonry apprentices. BMC Public Health. 2016 Apr 27;16:362. doi: 10.1186/s12889-016-2989-x.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomics training and/or Safety Voice training in people with Work Related Musculoskeletal Disorders, run by Eastern Washington University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. 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?
Results are not available in the source record.
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?
Modified Nordic Questionnaire (time frame: Change from baseline through study completion, an average of 1 year). The study lists 6 primary outcomes in all. 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 NCT02676635, which also lists 1 linked publication.
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 7 Sep 2018.