NCT02676635

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

3.5 years

First QC Date

January 28, 2016

Last Update Submit

September 6, 2018

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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?"

    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.

    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).

    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.

    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).

    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.

    Change from baseline through study completion, an average of 1 year

Study Arms (3)

Ergonomics Training Only

EXPERIMENTAL

Participants in this arm receive Ergonomics training only

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

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

Interventions

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.

Ergonomics Training OnlyErgonomics and Safety Voice Training

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Apprentices who do not have reliable access to a computer or who do not use a cell phone will be excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Washington University

Spokane, Washington, 99202, United States

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations