Work Disability Reduction and PreventionNCT02309996
SMART Supervisor Training Program to Prevent Work Disability
A study testing Supervisor Training Program in people with Work Disability Reduction and Prevention and Improving Return-to-Work Outcomes, run by Lakehead University at 1 site in Canada.
Trial summary
Supervisors of injured workers play a key role in preventing prolonged work absences. Providing supervisors with tools to improve their response to musculoskeletal and other workplace injuries or illnesses may improve worker health and disability outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work Disability Reduction and Prevention, Improving Return-to-Work Outcomes
- What is being tested?
- Supervisor Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Dec 2018
- 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
- Supervisors
- Currently employed at the work units selected by participating employers
- Supervise at least one working employee (i.e., non-supervisor)
- Would deal with issues of work accommodation should the need arise
Who cannot join
- Higher level supervisors who only supervise lower-level supervisors
- Do not speak/read English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Lakehead University
Thunder Bay, Ontario, P7B5E1
Vicki L Kristman, PhD
About this study
Official title: A Supervisor Training Program for Work Disability Prevention: A Cluster RCT
Supervisors of injured workers play a key role in preventing prolonged work absences. Providing supervisors with tools to improve their response to musculoskeletal and other workplace injuries or illnesses may improve worker health and disability outcomes.
The primary objective of this research study is to determine the effectiveness of the supervisor training program, the SMART Supervisor Training Program, on reducing the total duration of workers' lost-time claims. The secondary objectives are 1) to determine the effectiveness of the training program on reducing the cumulative incidence of workers' lost-time injuries and sick leave days; 2) to determine if implementation of the training program is associated with improvements in hypothesized mediating variables, such as attitudes toward job accommodations, response to workplace injury, and communication with employees and healthcare providers; 3) to investigate the implementation of the training program by conducting a process evaluation.
Read more
The investigators hypothesize that:
- the duration of lost-time claims for workers working under supervisors receiving the training program will be shorter than the duration of lost-time claims for workers with supervisors in the control group;
- the cumulative incidence of lost-time injuries and sick leave days will be lower in the group receiving the training program compared to the control group;
- the training program will be associated with increased knowledge, response, communication and changed attitudes towards workplace accommodation.
This research is of significance to North American employers and compensation systems because there is a lack of knowledge about the usefulness of supervisor training to prevent or reduce work disability. It also has important implications for guiding employer policies and practices, and for identifying circumstances where supervisor training should be a priority.
Read the detailed description
This study is a multi-centred, cluster randomized, controlled, single-blinded, fixed sample trial.
The project will involve several large Canadian and American employers. Participating work units within the organizations will be randomly assigned to either the training program (intervention group) or not (control group). Randomizing geographically separate work units works best to prevent contamination of supervisors selected to be the control group. However, the employer will decide what constitutes a work unit (e.g., separate building, division, etc.). The work units will be pair-matched into clusters based on number of employees, gender proportions, and work tasks as best as possible. A total of 86 work units (43 work unit pairs) including approximately 350 supervisors is required to achieve the primary objective, with fewer work units and supervisors required to achieve the secondary objectives. Within each cluster, one work unit will receive the training program and the other will act as the control. All supervisors within those work units randomized to receive the intervention will attend a four-hour supervisor training session. Before training is administered to the randomly assigned work units, all supervisors (intervention group and control group) will receive an email with an attached information pamphlet about principles for successful return to work. The purpose of the information pamphlet is to minimize the Hawthorne Effect, whereby subjects change their behaviour in response to the knowledge that they are being studied or monitored.
The work disability outcomes (duration of lost-time injuries in days, and cumulative incidence of lost-time injuries and sick leave days) will be determined from workplace records, and outcomes data will be extracted and analyzed at the level of the work unit. Since the intervention is a training program, it is impossible to blind the participating supervisors. However, the data extractor and individuals working in each employer's Occupational Health \& Safety Department will be blinded to the results of the work unit randomization and no other workers will be informed if the supervisors in their work unit received the training program or not.
To collect information about the hypothesized mediating variables, consenting supervisors will be asked to complete three online questionnaires: baseline and two follow-up questionnaires (three and six months post-randomization). The baseline and follow-up questionnaires will also collect information on potential moderating and confounding factors including workplace safety culture, supervisor autonomy, corporate disability management, leadership style, workplace social capital, and workers' physical work demands, supervisor demographics, and characteristics of supervised workers (e.g., number, gender proportions, unionization status). Analysis of the mediating variables will be conducted at the level of the work unit. Data for the process evaluation will be obtained from a brief exit training program evaluation survey distributed to participants in the intervention group as well as the three and six month follow-up questionnaires.
This is a pragmatic, intent-to-treat trail, so participants will be analyzed according to the group they were randomly assigned to. However, the investigators will also obtain information about supervisor transfers among work units (and the direction of the transfers) for the one year period post-randomization to understand how such transfers may have influenced the results.
- Being tested
- Supervisor Training Program
- Keywords
- Randomized Controlled Trial, Intervention Studies, Inservice Training, Personnel Management, Work place, Work accommodation, Job modification, Supervision, Administration, Return to Work, Industrial Psychology, Human Engineering, Risk Management, Organization and Administration, Work Disability, Occupational Diseases, Occupational Injury, Occupational Health, Occupational Exposure, Sick Leave
- Medical subject headings
- Occupational Diseases, Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervisor Training ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Supervisor Training Program | Experimental | All supervisors from work units randomized to the intervention will receive a supervisor training program, the Supervisor/Manager Accommodation Recognition \& Training (SMART) Program. This training program is modeled on a program developed by Shaw and colleagues of the Liberty Mutual Research Institute for Safety (LMRIS). The aim of the training program is to prevent/reduce work disability by improving supervisor communication, response to workplace injury, and problem solving mechanisms. The training program is designed to be administered by two facilitators to groups of 10 to 12 supervisors, during one 4-hour session or two 2-hour sessions. The training program delivery mode includes PowerPoint presentation with supplementary audio or video segments, case studies, and group discussion. Receives: Behavioral: Supervisor Training Program |
| No Supervisor Training Program | No intervention | All supervisors from work units randomized to the control group will not receive the supervisor training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration of workers' lost-time claims due to injury or illness for existing and new claims
Aggregated lost-time due to injury or illness.
Measured: 1 year period post-randomization
Secondary outcomes (17)
Cumulative incidence of workers' lost-time injuries
Summing all new cases of lost-time injuries across worker groups..
Measured: 1 year period post-randomization
Total number of workers' sick leave days
Summing up sick leave days across worker groups.
Measured: 1 year period post-randomization
Job Accommodation Scale (JAS)
The JAS is a 21-item self-report measure developed to assess the likelihood that various job modification might be supported in the workplace. For more information see:
- S. Shaw, V. L. Kristman, K. Williams Whitt, S. Soklaridis, Y. Huang, P. Côté and P. Loisel. 2014. The Job Accommodation Scale (JAS): psychometric evaluation of a new measure of employer support for temporary job modifications. Journal of Occupational Rehabilitation 24 (4): 755-765.
Measured: Baseline, 3 months, 6 months
Supervisor's Role in Rehabilitation Questionnaire
This instrument asks supervisors to rank their self-efficacy to engage in all of the rehabilitation tasks associated with vocational rehabilitation. The survey uses a series of Likert scales, using response categories which classify each rehabilitation task as either being: "very difficult to do"; "hard to do"; "easy to do"; or "very simple to do". This scale is seen as a continuum of supervisor ability, and a measure of their self-rated capacity to engage in vocational rehabilitation at their own workplaces. The reliability estimate for the use of this rating scale is acceptable (Cronbach alpha = 0.89) and Rasch analysis supports the premise that all 20 rehabilitation items being estimated are unidimensional.
- Blackman and K. Chiveralls. 2011. Factors influencing workplace supervisor readiness to engage in workplace-based vocational rehabilitation. Journal of Occupational Rehabilitation 21 (4): 537-546.
Measured: Baseline, 3 months, 6 months
Behaviour Measure for Supervisors to Support Return to Work (SSRW) questionnaire
The SSRW was developed using supervisor and employee populations and there is a version for supervisors and a version for employers. The 42 items in the scale are related to supervisor behaviours during an employee's absence from work and subsequent return to work. The measure consists of four sub-scales: communication and support during sick leave, inclusive behaviour upon initial return, negative behaviours and general proactive support following return to work. A total score is obtained by summing the responses, with a higher score indicating more supportive behaviours. The measure has good internal consistency, test-retest reliability, and construct validity. The SSRW will be included in the 6-month follow-up questionnaire only.
- Munir, J. Yarker, B. Hicks and E. Donaldson Feilder. 2012. Returning employees back to work: developing a measure for Supervisors to Support Return to Work (SSRW). Journal of Occupational Rehabilitation 22 (2): 196-208.
Measured: 6 months
Supervisor Support Scale from the "Readiness for RTW Study"
The supervisor support scale was designed to assess the relations between injured workers and supervisors. This scale is based on items from a previously used questionnaire and also includes items developed by a clinical psychologist, organizational psychologist, psychometrist, and a graduate student in community health. Although this scale was originally developed for response by injured workers, we modified the 8-item scale for supervisor response. We will average all responses not indicating "Don't Know" to determine a supervisor support score from 1 to 4 where higher scores indicate better supervisor interaction.
- Franche, C. N. Severin, S. Hogg Johnson, H. Lee, P. Côté and N. Krause. 2009. A multivariate analysis of factors associated with early offer and acceptance of a work accommodation following an occupational musculoskeletal injury. Journal of occupational and environmental medicine 51 (8): 969-983.
Measured: Baseline, 3 months, 6 months
Supervisory Behavior Questionnaire
The supervisory behaviour scale was designed to assess positive supervisory behaviour regarding communication with the employee, promotion of gradual return to work, and consultation with other professionals. The scale includes 7 statements about interactions between supervisors and injured workers and asks supervisors to indicate how much they agree or disagree with each statement. Responses to all statements will be summed and will result in a final score between 7 and 35 where lower scores indicate positive supervisor behaviour.
- Nieuwenhuijsen, J. H. Verbeek, A. G. de Boer, R. W. Blonk and F. J. van Dijk. 2004. Supervisory behaviour as a predictor of return to work in employees absent from work due to mental health problems. Occupational and Environmental Medicine 61 (10): 817-823.
Measured: Baseline, 3 months, 6 months
Supervisor and Healthcare Provider Interactions questionnaire
Communication with healthcare providers will be measured with a questionnaire assessing supervisors' interactions with healthcare providers developed specifically for the mixed-methods study. The five questions were selected from existing publications as we could not find an existing scale appropriate for our needs through the literature review. Three constructs will be measured from these questions including healthcare communication (i.e., do you communicate with providers?), healthcare beliefs (i.e., does the supervisor believe the provider understands the nature of the job?), and healthcare information (i.e., how often does a provider help you return a worker to work?). The scale has good face validity and reliability in the supervisor population as determined from our previous project.
Measured: Baseline, 3 months, 6 months
Global Work Safety Climate (GWSC) Scale
A 6-item measure that assesses global work safety climate. For more information:
S.E. Hahn. 2008. A short scale for measuring safety climate. Safety science 46 (7): 1047-1066.
Measured: Baseline, 6 months
Organizational Policies and Practices (OPP) Scale (13 questions about organizational disability management policies and practices)
Amick BC III, Habeck RV, Hunt A, et al. Measuring the impact of organizational behaviors on work disability prevention and management. Journal of Occupational Rehabilitation 10 (1): 21-38.
Measured: Baseline
Supervisor Autonomy for Provision of Job Accommodations questions
Three questions using a likert scale.
Measured: Baseline
Leader Behavior Description Questionnaire (LBDQ)
Halpin AW. Manual for the Leader Behaviour Description Questionnaire. Columbus, OH:Bureau of Business Research, Ohio State University, 1957.
Measured: Baseline, 3 months
Physical Workload Questionnaire (PWQ)
Bot SDM, Terwee CB, van der Windt DAWM, et al. Internal consistency and validity of anew physical workload questionnaire. Occupational and Environmental Medicine 2004;61:980-86.
Measured: Baseline
Training program reach (proportion of the target group that participates)
Calculation of the percentage of supervisors that participate in the training.
Measured: Up to 1 month post-randomization
Training program dose delivered (efforts of the trainers)
Training program dose delivered (efforts of the trainers).
Measured: Up to 1 month post-randomization
Training program dose received (extent to which the supervisors have followed the training)
Training program dose received (extent to which the supervisors have followed the training).
Measured: Up to 1 month post-randomization
Training program fidelity (extent to which the training program was delivered according to the protocol)
Training program fidelity (extent to which the training program was delivered according to the protocol)
Measured: Up to 1 month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Disability Reduction and PreventionStudies 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Liberty Mutual Research Institute for Safety, Institute for Work & Health
- Responsible party
- Principal investigator, Vicki Kristman, Lakehead University
- Investigators
- Vicki L Kristman, PhD, Principal investigator, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309996
- Sponsor's protocol ID
- MOP-130505
- Status last verified
- Aug 2017
- First submitted
- 2 Dec 2014
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supervisor Training Program for Work Disability Prevention: A Cluster RCT
- ClinicalTrials.gov ID
- NCT02309996
- Acronym / sponsor ID
- MOP-130505
- Keywords
- Randomized Controlled Trial, Intervention Studies, Inservice Training, Personnel Management, Work place, Work accommodation, Job modification, Supervision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Liberty Mutual Research Institute for Safety, Institute for Work & Health
- Study start
- Dec 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Dec 2014 (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.
Supervisors of injured workers play a key role in preventing prolonged work absences. Providing supervisors with tools to improve their response to musculoskeletal and other workplace injuries or illnesses may improve worker health and disability outcomes.
The primary objective of this research study is to determine the effectiveness of the supervisor training program, the SMART Supervisor Training Program, on reducing the total duration of workers' lost-time claims. The secondary objectives are 1) to determine the effectiveness of the training program on reducing the cumulative incidence of workers' lost-time injuries and sick leave days; 2) to determine if implementation of the training program is associated with improvements in hypothesized mediating variables, such as attitudes toward job accommodations, response to workplace injury, and communication with employees and healthcare providers; 3) to investigate the implementation of the training program by conducting a process evaluation.
The investigators hypothesize that:
- the duration of lost-time claims for workers working under supervisors receiving the training program will be shorter than the duration of lost-time claims for workers with supervisors in the control group;
- the cumulative incidence of lost-time injuries and sick leave days will be lower in the group receiving the training program compared to the control group;
- the training program will be associated with increased knowledge, response, communication and changed attitudes towards workplace accommodation.
This research is of significance to North American employers and compensation systems because there is a lack of knowledge about the usefulness of supervisor training to prevent or reduce work disability. It also has important implications for guiding employer policies and practices, and for identifying circumstances where supervisor training should be a priority.
Detailed description
This study is a multi-centred, cluster randomized, controlled, single-blinded, fixed sample trial.
The project will involve several large Canadian and American employers. Participating work units within the organizations will be randomly assigned to either the training program (intervention group) or not (control group). Randomizing geographically separate work units works best to prevent contamination of supervisors selected to be the control group. However, the employer will decide what constitutes a work unit (e.g., separate building, division, etc.). The work units will be pair-matched into clusters based on number of employees, gender proportions, and work tasks as best as possible. A total of 86 work units (43 work unit pairs) including approximately 350 supervisors is required to achieve the primary objective, with fewer work units and supervisors required to achieve the secondary objectives. Within each cluster, one work unit will receive the training program and the other will act as the control. All supervisors within those work units randomized to receive the intervention will attend a four-hour supervisor training session. Before training is administered to the randomly assigned work units, all supervisors (intervention group and control group) will receive an email with an attached information pamphlet about principles for successful return to work. The purpose of the information pamphlet is to minimize the Hawthorne Effect, whereby subjects change their behaviour in response to the knowledge that they are being studied or monitored.
The work disability outcomes (duration of lost-time injuries in days, and cumulative incidence of lost-time injuries and sick leave days) will be determined from workplace records, and outcomes data will be extracted and analyzed at the level of the work unit. Since the intervention is a training program, it is impossible to blind the participating supervisors. However, the data extractor and individuals working in each employer's Occupational Health \& Safety Department will be blinded to the results of the work unit randomization and no other workers will be informed if the supervisors in their work unit received the training program or not.
To collect information about the hypothesized mediating variables, consenting supervisors will be asked to complete three online questionnaires: baseline and two follow-up questionnaires (three and six months post-randomization). The baseline and follow-up questionnaires will also collect information on potential moderating and confounding factors including workplace safety culture, supervisor autonomy, corporate disability management, leadership style, workplace social capital, and workers' physical work demands, supervisor demographics, and characteristics of supervised workers (e.g., number, gender proportions, unionization status). Analysis of the mediating variables will be conducted at the level of the work unit. Data for the process evaluation will be obtained from a brief exit training program evaluation survey distributed to participants in the intervention group as well as the three and six month follow-up questionnaires.
This is a pragmatic, intent-to-treat trail, so participants will be analyzed according to the group they were randomly assigned to. However, the investigators will also obtain information about supervisor transfers among work units (and the direction of the transfers) for the one year period post-randomization to understand how such transfers may have influenced the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervisor Training Program | Experimental | Behavioral: Supervisor Training ProgramAll supervisors from work units randomized to the intervention will receive a supervisor training program, the Supervisor/Manager Accommodation Recognition \& Training (SMART) Program. This training program is modeled on a program developed by Shaw and colleagues of the Liberty Mutual Research Institute for Safety (LMRIS). The aim of the training program is to prevent/reduce work disability by improving supervisor communication, response to workplace injury, and problem solving mechanisms. The training program is designed to be administered by two facilitators to groups of 10 to 12 supervisors, during one 4-hour session or two 2-hour sessions. The training program delivery mode includes PowerPoint presentation with supplementary audio or video segments, case studies, and group discussion. |
| No Supervisor Training Program | No intervention | –All supervisors from work units randomized to the control group will not receive the supervisor training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Supervisors
- Currently employed at the work units selected by participating employers
- Supervise at least one working employee (i.e., non-supervisor)
- Would deal with issues of work accommodation should the need arise
Key exclusion criteria (2 listed)
- Higher level supervisors who only supervise lower-level supervisors
- Do not speak/read English
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 |
|---|---|---|
| Supervisor Training Program | Behavioural | Supervisor Training Program |
Primary outcome
Total duration of workers' lost-time claims due to injury or illness for existing and new claims
Time frame: 1 year period post-randomization
Aggregated lost-time due to injury or illness.
17 secondary outcomes
Cumulative incidence of workers' lost-time injuries
Time frame: 1 year period post-randomization
Total number of workers' sick leave days
Time frame: 1 year period post-randomization
Job Accommodation Scale (JAS)
Time frame: Baseline, 3 months, 6 months
Supervisor's Role in Rehabilitation Questionnaire
Time frame: Baseline, 3 months, 6 months
Behaviour Measure for Supervisors to Support Return to Work (SSRW) questionnaire
Time frame: 6 months
Supervisor Support Scale from the "Readiness for RTW Study"
Time frame: Baseline, 3 months, 6 months
Supervisory Behavior Questionnaire
Time frame: Baseline, 3 months, 6 months
Supervisor and Healthcare Provider Interactions questionnaire
Time frame: Baseline, 3 months, 6 months
Global Work Safety Climate (GWSC) Scale
Time frame: Baseline, 6 months
Organizational Policies and Practices (OPP) Scale (13 questions about organizational disability management policies and practices)
Time frame: Baseline
Supervisor Autonomy for Provision of Job Accommodations questions
Time frame: Baseline
Leader Behavior Description Questionnaire (LBDQ)
Time frame: Baseline, 3 months
Physical Workload Questionnaire (PWQ)
Time frame: Baseline
Training program reach (proportion of the target group that participates)
Time frame: Up to 1 month post-randomization
Training program dose delivered (efforts of the trainers)
Time frame: Up to 1 month post-randomization
Training program dose received (extent to which the supervisors have followed the training)
Time frame: Up to 1 month post-randomization
Training program fidelity (extent to which the training program was delivered according to the protocol)
Time frame: Up to 1 month post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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.
Vicki L Kristman, PhD principal investigator
Lakehead University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervisor Training Program in people with Work Disability Reduction and Prevention and Improving Return-to-Work Outcomes, run by Lakehead University at 1 site in Canada.
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 2 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 24 Aug 2017. 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 Canada. 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?
Contact Vicki L Kristman, PhD (807-343-8961, vkristman@lakeheadu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of workers' lost-time claims due to injury or illness for existing and new claims (time frame: 1 year period post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2017.