Health BehaviorNCT01841983
Project A: Integrated Approaches to Improving the Health and Safety of Health Care Workers
A study testing Be Well Work Well in people with Health Behavior and Sleep, run by Harvard School of Public Health (HSPH) at 3 sites in United States.
Trial summary
While most of the research on integrated approaches of occupational health and safety and worksite health promotion to date has focused on manufacturing settings, employment is shifting to the service sector. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Behavior, Sleep, MSDs
- What is being tested?
- Be Well Work Well
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,500 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2012to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult and pediatric in-patient care units at Massachusetts General Hospital that have ceiling lifts in place (n=42 units) are eligible for the intervention.
- Patient care workers, including registered nurses (RNs), licensed practical nurses (LPNs), patient care assistants (PCAs)/nursing assistants (NAs) and Nurse Leaders working in in-patient units for at least 20 hours per week (n= 9500).
- Of those patient care workers, those working in adult and pediatric in-patient care units (n=90 units) are eligible to be randomly selected for surveys.
Who cannot join
- N/A
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Harvard School of Public Health
Boston, Massachusetts, 02115
About this study
While most of the research on integrated approaches of occupational health and safety and worksite health promotion to date has focused on manufacturing settings, employment is shifting to the service sector. Within this sector, health care employs over 12 million workers, and is the second fastest growing industry in the U.S. economy. In contrast to workers in other industries, rates of occupational injuries and illnesses among health care workers have increased over the past decade. The purpose of this study is to lay the foundation for integrated interventions in health care through examination of the associations of worker health outcomes and risks on and off the job with work policies and practices and to address the prevalent issues of musculoskeletal disorders (MSDs), particularly low back pain disability (LBPD), and health promotions through physical activity among patient care workers. The specific aims of this study are:
- To estimate the efficacy and determine the feasibility of an integrated intervention, addressing both health protection and health promotion in order to reduce MSD symptoms and improve health behaviors among healthcare workers. We will assess between-group differences in MSD symptoms, health behaviors, including physical activity, and a set of secondary outcomes, including unplanned absence, reported injuries, worker compensation claims and costs, turnover and retention, intention to leave the job, and work-role function. This study will explore the working hypothesis that: Workers employed at baseline in patient-care units receiving the intervention will report greater reductions in their MSD symptoms (primary outcome) and greater improvements in health behaviors, compared with workers employed at baseline in units assigned to the Usual Care control group.
- To determine the factors in the work environment which contribute over time to reductions in MSD symptoms and improvements in safe and healthy behaviors. (1) The work environment, work organization, and psychosocial factors, measured in our current study, will be associated with changes in workers' health behaviors and health outcomes between the assessments in the current and proposed studies; (2) Improvements in the work environment over time will be associated with improvements in workers' health behaviors and health outcomes. We will conduct multilevel modeling analysis to evaluate the simultaneous effects of worker-level and unit-level factors on MSD symptoms and safety and health behaviors.
Read the detailed description
Improving and protecting the health and well-being of healthcare workers requires addressing key risks in the work environment as well as promoting safe and healthy behaviors. Healthcare workers are at elevated risk for musculoskeletal disorders (MSDs) due to a range of job factors, including lifting and transferring patients; working long hours (often at night); and limited control over decisions on the job. Among these, nurses and nurses aides bear the largest burden of injury. Back injuries in particular constitute the greatest source of their disability. These risks are likely to increase in coming years due to the aging nursing workforce, increase in work demands, and labor shortages. Health behaviors, including physical activity, inadequate sleep, and dietary patterns associated with being overweight or obese, are also influenced by the work environment and psychosocial factors on the job, and are also associated with MSD risk. Traditional approaches to redressing these risks have focused separately on health protection, including efforts to reduce MSD risk, and health promotion aimed at improving health behaviors. Little research has systematically examined the dual and potentially synergistic effects of the work environment on risk of MSDs and worker health behaviors, and there is insufficient evidence to determine the most efficacious ways to ameliorate the combined effects of these health risks. Our long-term goal is to improve the overall health and well-being of healthcare workers by making available evidence-based worksite policies, programs, and practices that foster a healthy work environment, reduce potential hazardous job exposures, and promote safe and healthy behaviors. The proposed study is the next logical step in building this evidence base. Factors in the work environment, including high work demands, low social support, and long work hours, have been shown to increase risk of MSDs, as well as risk-related behaviors. Yet little research has systematically explored these cross-cutting pathways and their implications for improving the effectiveness of worksite interventions to address the broad spectrum of worker health outcomes.
The proposed research provides a novel approach to worksite interventions that integrate occupational safety and health and worksite health promotion, taking into account the shared factors in the work environment shaping both MSDs and health behaviors. Standard approaches to occupational health and safety and worksite health promotion are based on a parallel structure of separate silos functioning relatively independently in the worksite, each drawing from their own disciplines and training experiences within public health. Although these parallel efforts share the common mission of improving worker health, their strategies are based on different assumptions about and approaches to improving worker health outcomes. The proposed research integrates these parallel approaches. Although our prior research has rigorously tested the efficacy of this integrated intervention model in changing worker health behaviors, to our knowledge no prior research has examined the impact of this integrated model on health outcomes associated with work exposures - here, notably, on MSD symptoms.
- Conditions
- Health Behavior, Sleep, MSDs, Dietary Habits, Physical Activity
- Being tested
- Be Well Work Well
- Keywords
- Total worker health, Sleep, MSDs, Diet, Physical Activity
- Medical subject headings
- Health Behavior, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be Well Work WellOther
Also called OSH protection and health promotion program
The intervention follows principles for integrated approaches to promoting and protecting worker health. It will occur on 4 inpatient units at Massachusetts General Hospital beginning in January 2013, and will continue for 1 year.
Overall intervention objectives:
- Motivate individual staff members to engage in targeted health and safety behavior changes;
- build awareness of ergonomic and safety hazards and of opportunities for healthy dietary choices and physical activity;
- facilitate unit-level norms supportive of breaks, safe patient handling, and targeted health and safety behaviors; and
- promote co-worker and supervisor support for targeted health and safety behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Be Well Work Well Receives: Other: Be Well Work Well |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
- Musculoskeletal disorder pain
- Self-report via survey
Measured: Baseline and 1 year
Physical Activity
Self-report via survey
Measured: Baseline and 1 year
Diet
Self-report via survey
Measured: Baseline and 1 year
Sleep
Self-report via survey
Measured: Baseline and 1 year
Secondary outcomes (3)
Safe patient handling
Self-report via survey
Measured: Baseline and 1 year
Work role function/limitations
Self-report via survey
Measured: Baseline and 1 year
BMI/obesity
Self-report via survey
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Partners HealthCare, Brigham and Women's Hospital, Massachusetts General Hospital, Boston University, Carelon Research
- Responsible party
- Principal investigator, Glorian Sorensen, Harvard School of Public Health (HSPH)
- Investigators
- Glorian Sorensen, PhD, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841983
- Sponsor's protocol ID
- U19OH008861
- Status last verified
- May 2015
- First submitted
- 19 Mar 2013
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sembajwe G, Tveito TH, Hopcia K, Kenwood C, O'Day ET, Stoddard AM, Dennerlein JT, Hashimoto D, Sorensen G. Psychosocial stress and multi-site musculoskeletal pain: a cross-sectional survey of patient care workers. Workplace Health Saf. 2013 Mar;61(3):117-25. doi: 10.1177/216507991306100304.
PubMed 23452130Kim SS, Okechukwu CA, Dennerlein JT, Boden LI, Hopcia K, Hashimoto DM, Sorensen G. Association between perceived inadequate staffing and musculoskeletal pain among hospital patient care workers. Int Arch Occup Environ Health. 2014 Apr;87(3):323-30. doi: 10.1007/s00420-013-0864-y. Epub 2013 Mar 12.
PubMed 23475312Sabbath EL, Hurtado DA, Okechukwu CA, Tamers SL, Nelson C, Kim SS, Wagner G, Sorenson G. Occupational injury among hospital patient-care workers: what is the association with workplace verbal abuse? Am J Ind Med. 2014 Feb;57(2):222-32. doi: 10.1002/ajim.22271. Epub 2013 Oct 22.
PubMed 24151093Caspi CE, Dennerlein JT, Kenwood C, Stoddard AM, Hopcia K, Hashimoto D, Sorensen G. Results of a pilot intervention to improve health and safety for health care workers. J Occup Environ Med. 2013 Dec;55(12):1449-55. doi: 10.1097/JOM.0b013e3182a7e65a.
PubMed 24270297Sorensen G, McLellan D, Dennerlein JT, Pronk NP, Allen JD, Boden LI, Okechukwu CA, Hashimoto D, Stoddard A, Wagner GR. Integration of health protection and health promotion: rationale, indicators, and metrics. J Occup Environ Med. 2013 Dec;55(12 Suppl):S12-8. doi: 10.1097/JOM.0000000000000032.
PubMed 24284762Umukoro PE, Arias OE, Stoffel SD, Hopcia K, Sorensen G, Dennerlein JT. Physical activity at work contributes little to patient care workers' weekly totals. J Occup Environ Med. 2013 Dec;55(12 Suppl):S63-8. doi: 10.1097/JOM.0000000000000046.
PubMed 24284756Nelson CC, Wagner GR, Caban-Martinez AJ, Buxton OM, Kenwood CT, Sabbath EL, Hashimoto DM, Hopcia K, Allen J, Sorensen G. Physical activity and body mass index: the contribution of age and workplace characteristics. Am J Prev Med. 2014 Mar;46(3 Suppl 1):S42-51. doi: 10.1016/j.amepre.2013.10.035.
PubMed 24512930Kim SS, Okechukwu CA, Buxton OM, Dennerlein JT, Boden LI, Hashimoto DM, Sorensen G. Association between work-family conflict and musculoskeletal pain among hospital patient care workers. Am J Ind Med. 2013 Apr;56(4):488-95. doi: 10.1002/ajim.22120. Epub 2012 Sep 27.
PubMed 23019044Hopcia K, Dennerlein JT, Hashimoto D, Orechia T, Sorensen G. Occupational injuries for consecutive and cumulative shifts among hospital registered nurses and patient care associates: a case-control study. Workplace Health Saf. 2012 Oct;60(10):437-44. doi: 10.1177/216507991206001005. Epub 2012 Sep 24.
PubMed 22998692Buxton OM, Hopcia K, Sembajwe G, Porter JH, Dennerlein JT, Kenwood C, Stoddard AM, Hashimoto D, Sorensen G. Relationship of sleep deficiency to perceived pain and functional limitations in hospital patient care workers. J Occup Environ Med. 2012 Jul;54(7):851-8. doi: 10.1097/JOM.0b013e31824e6913.
PubMed 22796931Reme SE, Dennerlein JT, Hashimoto D, Sorensen G. Musculoskeletal pain and psychological distress in hospital patient care workers. J Occup Rehabil. 2012 Dec;22(4):503-10. doi: 10.1007/s10926-012-9361-5.
PubMed 22466375Dennerlein JT, Hopcia K, Sembajwe G, Kenwood C, Stoddard AM, Tveito TH, Hashimoto DM, Sorensen G. Ergonomic practices within patient care units are associated with musculoskeletal pain and limitations. Am J Ind Med. 2012 Feb;55(2):107-16. doi: 10.1002/ajim.21036. Epub 2011 Nov 23.
PubMed 22113975Boden LI, Sembajwe G, Tveito TH, Hashimoto D, Hopcia K, Kenwood C, Stoddard AM, Sorensen G. Occupational injuries among nurses and aides in a hospital setting. Am J Ind Med. 2012 Feb;55(2):117-26. doi: 10.1002/ajim.21018. Epub 2011 Oct 24.
PubMed 22025077Sorensen G, Stoddard AM, Stoffel S, Buxton O, Sembajwe G, Hashimoto D, Dennerlein JT, Hopcia K. The role of the work context in multiple wellness outcomes for hospital patient care workers. J Occup Environ Med. 2011 Aug;53(8):899-910. doi: 10.1097/JOM.0b013e318226a74a.
PubMed 21775897
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project A: Integrated Approaches to Improving the Health and Safety of Health Care Workers
- ClinicalTrials.gov ID
- NCT01841983
- Acronym / sponsor ID
- U19OH008861
- Conditions
- Health Behavior, Sleep, MSDs, Dietary Habits, Physical Activity
- Keywords
- Total worker health, Sleep, MSDs, Diet, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,500 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Partners HealthCare, Brigham and Women's Hospital, Massachusetts General Hospital, Boston University, Carelon Research
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Apr 2013 (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.
While most of the research on integrated approaches of occupational health and safety and worksite health promotion to date has focused on manufacturing settings, employment is shifting to the service sector. Within this sector, health care employs over 12 million workers, and is the second fastest growing industry in the U.S. economy. In contrast to workers in other industries, rates of occupational injuries and illnesses among health care workers have increased over the past decade. The purpose of this study is to lay the foundation for integrated interventions in health care through examination of the associations of worker health outcomes and risks on and off the job with work policies and practices and to address the prevalent issues of musculoskeletal disorders (MSDs), particularly low back pain disability (LBPD), and health promotions through physical activity among patient care workers. The specific aims of this study are:
- To estimate the efficacy and determine the feasibility of an integrated intervention, addressing both health protection and health promotion in order to reduce MSD symptoms and improve health behaviors among healthcare workers. We will assess between-group differences in MSD symptoms, health behaviors, including physical activity, and a set of secondary outcomes, including unplanned absence, reported injuries, worker compensation claims and costs, turnover and retention, intention to leave the job, and work-role function. This study will explore the working hypothesis that: Workers employed at baseline in patient-care units receiving the intervention will report greater reductions in their MSD symptoms (primary outcome) and greater improvements in health behaviors, compared with workers employed at baseline in units assigned to the Usual Care control group.
- To determine the factors in the work environment which contribute over time to reductions in MSD symptoms and improvements in safe and healthy behaviors. (1) The work environment, work organization, and psychosocial factors, measured in our current study, will be associated with changes in workers' health behaviors and health outcomes between the assessments in the current and proposed studies; (2) Improvements in the work environment over time will be associated with improvements in workers' health behaviors and health outcomes. We will conduct multilevel modeling analysis to evaluate the simultaneous effects of worker-level and unit-level factors on MSD symptoms and safety and health behaviors.
Detailed description
Improving and protecting the health and well-being of healthcare workers requires addressing key risks in the work environment as well as promoting safe and healthy behaviors. Healthcare workers are at elevated risk for musculoskeletal disorders (MSDs) due to a range of job factors, including lifting and transferring patients; working long hours (often at night); and limited control over decisions on the job. Among these, nurses and nurses aides bear the largest burden of injury. Back injuries in particular constitute the greatest source of their disability. These risks are likely to increase in coming years due to the aging nursing workforce, increase in work demands, and labor shortages. Health behaviors, including physical activity, inadequate sleep, and dietary patterns associated with being overweight or obese, are also influenced by the work environment and psychosocial factors on the job, and are also associated with MSD risk. Traditional approaches to redressing these risks have focused separately on health protection, including efforts to reduce MSD risk, and health promotion aimed at improving health behaviors. Little research has systematically examined the dual and potentially synergistic effects of the work environment on risk of MSDs and worker health behaviors, and there is insufficient evidence to determine the most efficacious ways to ameliorate the combined effects of these health risks. Our long-term goal is to improve the overall health and well-being of healthcare workers by making available evidence-based worksite policies, programs, and practices that foster a healthy work environment, reduce potential hazardous job exposures, and promote safe and healthy behaviors. The proposed study is the next logical step in building this evidence base. Factors in the work environment, including high work demands, low social support, and long work hours, have been shown to increase risk of MSDs, as well as risk-related behaviors. Yet little research has systematically explored these cross-cutting pathways and their implications for improving the effectiveness of worksite interventions to address the broad spectrum of worker health outcomes.
The proposed research provides a novel approach to worksite interventions that integrate occupational safety and health and worksite health promotion, taking into account the shared factors in the work environment shaping both MSDs and health behaviors. Standard approaches to occupational health and safety and worksite health promotion are based on a parallel structure of separate silos functioning relatively independently in the worksite, each drawing from their own disciplines and training experiences within public health. Although these parallel efforts share the common mission of improving worker health, their strategies are based on different assumptions about and approaches to improving worker health outcomes. The proposed research integrates these parallel approaches. Although our prior research has rigorously tested the efficacy of this integrated intervention model in changing worker health behaviors, to our knowledge no prior research has examined the impact of this integrated model on health outcomes associated with work exposures - here, notably, on MSD symptoms.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Be Well Work WellBe Well Work Well |
| Control | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult and pediatric in-patient care units at Massachusetts General Hospital that have ceiling lifts in place (n=42 units) are eligible for the intervention.
- Patient care workers, including registered nurses (RNs), licensed practical nurses (LPNs), patient care assistants (PCAs)/nursing assistants (NAs) and Nurse Leaders working in in-patient units for at least 20 hours per week (n= 9500).
- Of those patient care workers, those working in adult and pediatric in-patient care units (n=90 units) are eligible to be randomly selected for surveys.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Be Well Work WellAlso: OSH protection and health promotion programThe intervention follows principles for integrated approaches to promoting and protecting worker health. It will occur on 4 inpatient units at Massachusetts General Hospital beginning in January 2013, and will continue for 1 year. Overall intervention objectives: 1. Motivate individual staff members to engage in targeted health and safety behavior changes; 2. build awareness of ergonomic and safety hazards and of opportunities for healthy dietary choices and physical activity; 3. facilitate unit-level norms supportive of breaks, safe patient handling, and targeted health and safety behaviors; and 4. promote co-worker and supervisor support for targeted health and safety behaviors. | Other | Intervention |
Primary outcome
Pain
Time frame: Baseline and 1 year
* Musculoskeletal disorder pain * Self-report via survey
Physical Activity
Time frame: Baseline and 1 year
Self-report via survey
Diet
Time frame: Baseline and 1 year
Self-report via survey
Sleep
Time frame: Baseline and 1 year
Self-report via survey
3 secondary outcomes
Safe patient handling
Time frame: Baseline and 1 year
Work role function/limitations
Time frame: Baseline and 1 year
BMI/obesity
Time frame: Baseline and 1 year
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 7 May 2015.
- Background: PubMed 23452130Sembajwe G, Tveito TH, Hopcia K, Kenwood C, O'Day ET, Stoddard AM, Dennerlein JT, Hashimoto D, Sorensen G. Psychosocial stress and multi-site musculoskeletal pain: a cross-sectional survey of patient care workers. Workplace Health Saf. 2013 Mar;61(3):117-25. doi: 10.1177/216507991306100304.
- Background: PubMed 23475312Kim SS, Okechukwu CA, Dennerlein JT, Boden LI, Hopcia K, Hashimoto DM, Sorensen G. Association between perceived inadequate staffing and musculoskeletal pain among hospital patient care workers. Int Arch Occup Environ Health. 2014 Apr;87(3):323-30. doi: 10.1007/s00420-013-0864-y. Epub 2013 Mar 12.
- Background: PubMed 24151093Sabbath EL, Hurtado DA, Okechukwu CA, Tamers SL, Nelson C, Kim SS, Wagner G, Sorenson G. Occupational injury among hospital patient-care workers: what is the association with workplace verbal abuse? Am J Ind Med. 2014 Feb;57(2):222-32. doi: 10.1002/ajim.22271. Epub 2013 Oct 22.
- Background: PubMed 24270297Caspi CE, Dennerlein JT, Kenwood C, Stoddard AM, Hopcia K, Hashimoto D, Sorensen G. Results of a pilot intervention to improve health and safety for health care workers. J Occup Environ Med. 2013 Dec;55(12):1449-55. doi: 10.1097/JOM.0b013e3182a7e65a.
- Background: PubMed 24284762Sorensen G, McLellan D, Dennerlein JT, Pronk NP, Allen JD, Boden LI, Okechukwu CA, Hashimoto D, Stoddard A, Wagner GR. Integration of health protection and health promotion: rationale, indicators, and metrics. J Occup Environ Med. 2013 Dec;55(12 Suppl):S12-8. doi: 10.1097/JOM.0000000000000032.
- Background: PubMed 24284756Umukoro PE, Arias OE, Stoffel SD, Hopcia K, Sorensen G, Dennerlein JT. Physical activity at work contributes little to patient care workers' weekly totals. J Occup Environ Med. 2013 Dec;55(12 Suppl):S63-8. doi: 10.1097/JOM.0000000000000046.
- Background: PubMed 24512930Nelson CC, Wagner GR, Caban-Martinez AJ, Buxton OM, Kenwood CT, Sabbath EL, Hashimoto DM, Hopcia K, Allen J, Sorensen G. Physical activity and body mass index: the contribution of age and workplace characteristics. Am J Prev Med. 2014 Mar;46(3 Suppl 1):S42-51. doi: 10.1016/j.amepre.2013.10.035.
- Results publication: PubMed 23019044Kim SS, Okechukwu CA, Buxton OM, Dennerlein JT, Boden LI, Hashimoto DM, Sorensen G. Association between work-family conflict and musculoskeletal pain among hospital patient care workers. Am J Ind Med. 2013 Apr;56(4):488-95. doi: 10.1002/ajim.22120. Epub 2012 Sep 27.
- Results publication: PubMed 22998692Hopcia K, Dennerlein JT, Hashimoto D, Orechia T, Sorensen G. Occupational injuries for consecutive and cumulative shifts among hospital registered nurses and patient care associates: a case-control study. Workplace Health Saf. 2012 Oct;60(10):437-44. doi: 10.1177/216507991206001005. Epub 2012 Sep 24.
- Results publication: PubMed 22796931Buxton OM, Hopcia K, Sembajwe G, Porter JH, Dennerlein JT, Kenwood C, Stoddard AM, Hashimoto D, Sorensen G. Relationship of sleep deficiency to perceived pain and functional limitations in hospital patient care workers. J Occup Environ Med. 2012 Jul;54(7):851-8. doi: 10.1097/JOM.0b013e31824e6913.
- Results publication: PubMed 22466375Reme SE, Dennerlein JT, Hashimoto D, Sorensen G. Musculoskeletal pain and psychological distress in hospital patient care workers. J Occup Rehabil. 2012 Dec;22(4):503-10. doi: 10.1007/s10926-012-9361-5.
- Results publication: PubMed 22113975Dennerlein JT, Hopcia K, Sembajwe G, Kenwood C, Stoddard AM, Tveito TH, Hashimoto DM, Sorensen G. Ergonomic practices within patient care units are associated with musculoskeletal pain and limitations. Am J Ind Med. 2012 Feb;55(2):107-16. doi: 10.1002/ajim.21036. Epub 2011 Nov 23.
- Center for Work, Health, and WellbeingLink provided by the sponsor.
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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.
Glorian Sorensen, PhD, MPH principal investigator
Harvard School of Public Health (HSPH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be Well Work Well in people with Health Behavior and Sleep, run by Harvard School of Public Health (HSPH) at 3 sites 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 3 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: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Pain (time frame: Baseline and 1 year). The study lists 4 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 NCT01841983, which also lists 14 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 7 May 2015.