Chronic Physical Health ConditionsNCT01978392
MANAGE AT WORK: Addressing the Challenge of Chronic Physical Health Conditions in the Workplace
A study testing Self-management group workshops in people with Chronic Physical Health Conditions, run by Liberty Mutual Research Institute for Safety at 4 sites in United States.
Trial summary
The specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. The facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Physical Health Conditions
- What is being tested?
- Self-management group workshops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2013to 31 May 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Workers with at least one chronic physical condition (> 6 months).
- Working full time (at least 20 hours per week).
- Able to read and speak in English language.
Who cannot join
- Impending retirement or major career change (next 12 months).
- Not available to attend group workshops after working hours.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dartmouth-Hitchcock Medical Center
Hanover, New Hampshire, 03755
Employer #4 (Confidential)
Hanover, New Hampshire, 03755
Employer #2 (confidential)
Providence, Rhode Island
Employer #3 (confidential)
Worcester, Massachusetts
About this study
Official title: MANAGE AT WORK: Evaluation of a Group-based Self-management Program to Address Workplace Discomfort and Fatigue Associated With Chronic Physical Health Conditions
The specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. The facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. The workshops address issues of pain management, physical job demands, pacing of work, communication, problem solving, and coping. Half of the participants in the study will be randomly assigned to attend workshop sessions (10 hours total), and all study participants will be followed for one year. The primary hypothesis is that workers who participate in these workshops will show improvements in work engagement and reductions in work limitation in the subsequent 12 months.
Read the detailed description
One significant trend in the US workforce is the advancing median age of workers and the growing prevalence of chronic medical conditions that contribute to workplace pain, fatigue, task limitations, and reduced productivity. The proposed multi-site study is a randomized, controlled trial of a multi-session group intervention program targeting workers with chronic health concerns (N = 300). The primary outcome measures will be self-report measures of work limitations and work engagement measured at baseline, 6 months, and 12 months follow-up. Secondary outcomes will include turnover intention, sickness absence, job satisfaction, and healthcare utilization. Process variables and covariates will include assessment of self-efficacy, work-related fatigue, emotional distress, work characteristics, general health status, and basic demographic variables. The study should provide an assessment of whether principles of symptom self-management can be successfully applied to workplace problems and delivered in a group workshop format to reduce the disabling effects of chronic medical conditions.
- Conditions
- Chronic Physical Health Conditions
- Being tested
- Self-management group workshops
- Keywords
- disability, self-management, chronic illness, chronic pain, occupation, > 6 months
- Medical subject headings
- Chronic Disease, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management group workshopsBehavioural
This intervention consists of multiple group workshop sessions (10 hours total) led by a specially trained facilitator and provided over a span of approximately 2-3 months. The intervention incorporates standard elements of existing evidence-based pain and illness self-management efforts, but tailoring key messages and discussion elements to apply to workplace problems most relevant to workers with chronic medical conditions. Each session is focused on different self-management strategies, with each session containing a mix of facilitator presentation, group discussion, case illustrations, role-play, completion of in-session self-assessments and activities, and brief homework assignments. Approximately equal time is allocated to the topics of improving comfort, modifying work, communicating effectively, applying systematic problem-solving strategies, and dealing with negative thoughts and emotions.
| Study group | Role | What they receive |
|---|---|---|
| Self-management group workshops | Experimental | Self-management group workshops: Participants randomized to the intervention arm will be asked to participate in group workshop sessions (10 hours total) led by a specially trained facilitator and provided over a span of approximately 2-3 months. Receives: Behavioral: Self-management group workshops |
| No treament (wait-list control) | No intervention | Wait-list control: Participants randomized to the control arm will receive no intervention during the one-year period of data collection, but they will be invited to attend a full-day Saturday workshop after all study data collection is complete). The intent of the full-day workshop will be to provide the same self-management information as in the intervention arm, but on a delayed basis and in a more condensed format. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work limitations
The Work Limitations Questionnaire (WLQ)(Lerner et al., 2003) is a 25-item self-report questionnaire that assesses the degree to which working individuals are experiencing limitations on-the-job due to their health problems and health-related productivity loss. The WLQ asks respondents to rate their level of difficulty or ability to perform specific job demands. Items are grouped into 4 scales: (1) time management; (2) physical demands; (3) mental-interpersonal demands; and (4) output demands.
Measured: One year
Work engagement
The Utrecht Work Engagement Scale (UWES) (Demourati et al., 2001) is a 17-item self-report questionnaire that was designed to measure the degree to which employees have a sense of energetic and effective connection with their work activities (energy involvement) and see themselves as able to deal with the demands of their job (professional efficacy). Respondents rate their level of agreement with stated feelings about work on a 7-point likert scale from "never" to "always". Work engagement has been defined as a positive, fulfilling, work-related state of mind that is characterized by vigor, dedication, and absorption.
Measured: One year
Secondary outcomes (7)
Work fatigue
The Occupational Fatigue Exhaustion Recovery Scale (OFER) (Winwood et al., 2005) is a 20-item self-report questionnaire that assesses the degree to which job activities produce acute fatigue, deplete available energy, and reduce the ability to engage in pleasurable activities outside of work. Respondents rate their level of agreement on a 7-point likert scale from "completely disagree" to "completely agree".
Measured: One year
Turnover intention
A 4-item scale developed by Kelloway and colleagues (1999) will be used to assess turnover intentions. The four questions are: "I am thinking about leaving this organization", "I am planning to look for a new job", "I intend to ask people about new job opportunities", and "I don't plan to be in this organization much longer". Each item is rated on a 5-point likert scale from "strongly disagree" to "strongly agree".
Measured: One year
Job satisfaction
A 2-item scale developed from prior work by the researchers will be used to assess job satisfaction. The two questions are: "I like working for this company and expect to be here for another year or more" and "I would recommend this company to others".
Measured: One year
Self-efficacy
A unique self-efficacy measure was developed for the project to be closely aligned with the content of the workshop program. Ten items were adapted from the Pain Self-efficacy Questionnaire (Nicholas, 2007) and ten items were taken from the Return-to-work Self Efficacy (RTWSE-19) scale (Shaw et al., 2011). The goal of the new measure is to assess worker confidence with respect to symptom management, job modification, communication, emotional coping, and obtaining needed support and assistance.
Measured: One year
General health status
The Standard Form-36 (SF-36) (Ware et al., 1992) will be used to assess general health status. This is the most well-validated and frequently used measure of generic health status in health research. The SF-36 provides a single metric of health function regardless of diagnostic categories or illness classifications.
Measured: One year
Sickness absence
Participants will be asked to recall the number of days in the past 6 months that they were absent from work because of their health. Self-report has been shown to be a viable and reasonably accurate method for assessing sickness absence days in studies of employee health (Short et al., 2009).
Measured: One year
Healthcare utilization
Participants will be asked to recall the number and type of health care visits over the past 6 months using a standardized set of reporting options and prompts. Self-report has been shown to be a viable and reasonably accurate method for assessing health care utilization rates in studies of employee health (Short et al., 2009) and among individuals with chronic medical conditions (Lubeck \& Hubert, 2005).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Physical Health ConditionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberty Mutual Research Institute for Safety
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William S Shaw, Ph.D., Principal investigator, Liberty Mutual Research Institute for Safety
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978392
- Sponsor's protocol ID
- LMRIS 11-08
- Other IDs
- LMRIS Project 11-08
- Status last verified
- Jun 2017
- First submitted
- 1 Nov 2013
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data may be available to qualified researchers after data collection is complete
Publications
Tveito TH, Shaw WS, Huang YH, Nicholas M, Wagner G. Managing pain in the workplace: a focus group study of challenges, strategies and what matters most to workers with low back pain. Disabil Rehabil. 2010;32(24):2035-45. doi: 10.3109/09638281003797398. Epub 2010 Sep 23.
PubMed 20860528Shaw WS, Tveito TH, Geehern-Lavoie M, Huang YH, Nicholas MK, Reme SE, Wagner G, Pransky G. Adapting principles of chronic pain self-management to the workplace. Disabil Rehabil. 2012;34(8):694-703. doi: 10.3109/09638288.2011.615372. Epub 2011 Oct 17.
PubMed 22004668Shaw WS, Tveito TH, Boot CR. Introduction to the special section: sustainability of work with chronic health conditions. J Occup Rehabil. 2013 Jun;23(2):157-61. doi: 10.1007/s10926-013-9448-7.
PubMed 23625029Shaw WS, McLellan RK, Besen E, Namazi S, Nicholas MK, Dugan AG, Tveito TH. A Worksite Self-management Program for Workers with Chronic Health Conditions Improves Worker Engagement and Retention, but not Workplace Function. J Occup Rehabil. 2022 Mar;32(1):77-86. doi: 10.1007/s10926-021-09983-6. Epub 2021 May 13.
PubMed 33983524Shaw WS, Besen E, Pransky G, Boot CR, Nicholas MK, McLellan RK, Tveito TH. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions. BMC Public Health. 2014 May 28;14:515. doi: 10.1186/1471-2458-14-515.
PubMed 24885844
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANAGE AT WORK: Evaluation of a Group-based Self-management Program to Address Workplace Discomfort and Fatigue Associated With Chronic Physical Health Conditions
- ClinicalTrials.gov ID
- NCT01978392
- Acronym / sponsor ID
- LMRIS 11-08
- Conditions
- Chronic Physical Health Conditions
- Keywords
- disability, self-management, chronic illness, chronic pain, occupation, > 6 months
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Liberty Mutual Research Institute for SafetyIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 7 Nov 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.
The specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. The facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. The workshops address issues of pain management, physical job demands, pacing of work, communication, problem solving, and coping. Half of the participants in the study will be randomly assigned to attend workshop sessions (10 hours total), and all study participants will be followed for one year. The primary hypothesis is that workers who participate in these workshops will show improvements in work engagement and reductions in work limitation in the subsequent 12 months.
Detailed description
One significant trend in the US workforce is the advancing median age of workers and the growing prevalence of chronic medical conditions that contribute to workplace pain, fatigue, task limitations, and reduced productivity. The proposed multi-site study is a randomized, controlled trial of a multi-session group intervention program targeting workers with chronic health concerns (N = 300). The primary outcome measures will be self-report measures of work limitations and work engagement measured at baseline, 6 months, and 12 months follow-up. Secondary outcomes will include turnover intention, sickness absence, job satisfaction, and healthcare utilization. Process variables and covariates will include assessment of self-efficacy, work-related fatigue, emotional distress, work characteristics, general health status, and basic demographic variables. The study should provide an assessment of whether principles of symptom self-management can be successfully applied to workplace problems and delivered in a group workshop format to reduce the disabling effects of chronic medical conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management group workshops | Experimental | Behavioral: Self-management group workshopsSelf-management group workshops: Participants randomized to the intervention arm will be asked to participate in group workshop sessions (10 hours total) led by a specially trained facilitator and provided over a span of approximately 2-3 months. |
| No treament (wait-list control) | No intervention | –Wait-list control: Participants randomized to the control arm will receive no intervention during the one-year period of data collection, but they will be invited to attend a full-day Saturday workshop after all study data collection is complete). The intent of the full-day workshop will be to provide the same self-management information as in the intervention arm, but on a delayed basis and in a more condensed format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Workers with at least one chronic physical condition (> 6 months).
- Working full time (at least 20 hours per week).
- Able to read and speak in English language.
Key exclusion criteria (2 listed)
- Impending retirement or major career change (next 12 months).
- Not available to attend group workshops after working hours.
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 |
|---|---|---|
| Self-management group workshopsThis intervention consists of multiple group workshop sessions (10 hours total) led by a specially trained facilitator and provided over a span of approximately 2-3 months. The intervention incorporates standard elements of existing evidence-based pain and illness self-management efforts, but tailoring key messages and discussion elements to apply to workplace problems most relevant to workers with chronic medical conditions. Each session is focused on different self-management strategies, with each session containing a mix of facilitator presentation, group discussion, case illustrations, role-play, completion of in-session self-assessments and activities, and brief homework assignments. Approximately equal time is allocated to the topics of improving comfort, modifying work, communicating effectively, applying systematic problem-solving strategies, and dealing with negative thoughts and emotions. | Behavioural | Self-management group workshops |
Primary outcome
Work limitations
Time frame: One year
The Work Limitations Questionnaire (WLQ)(Lerner et al., 2003) is a 25-item self-report questionnaire that assesses the degree to which working individuals are experiencing limitations on-the-job due to their health problems and health-related productivity loss. The WLQ asks respondents to rate their level of difficulty or ability to perform specific job demands. Items are grouped into 4 scales: (1) time management; (2) physical demands; (3) mental-interpersonal demands; and (4) output demands.
Work engagement
Time frame: One year
The Utrecht Work Engagement Scale (UWES) (Demourati et al., 2001) is a 17-item self-report questionnaire that was designed to measure the degree to which employees have a sense of energetic and effective connection with their work activities (energy involvement) and see themselves as able to deal with the demands of their job (professional efficacy). Respondents rate their level of agreement with stated feelings about work on a 7-point likert scale from "never" to "always". Work engagement has been defined as a positive, fulfilling, work-related state of mind that is characterized by vigor, dedication, and absorption.
7 secondary outcomes
Work fatigue
Time frame: One year
Turnover intention
Time frame: One year
Job satisfaction
Time frame: One year
Self-efficacy
Time frame: One year
General health status
Time frame: One year
Sickness absence
Time frame: One year
Healthcare utilization
Time frame: One 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 2 Jun 2017.
- Background: PubMed 20860528Tveito TH, Shaw WS, Huang YH, Nicholas M, Wagner G. Managing pain in the workplace: a focus group study of challenges, strategies and what matters most to workers with low back pain. Disabil Rehabil. 2010;32(24):2035-45. doi: 10.3109/09638281003797398. Epub 2010 Sep 23.
- Background: PubMed 22004668Shaw WS, Tveito TH, Geehern-Lavoie M, Huang YH, Nicholas MK, Reme SE, Wagner G, Pransky G. Adapting principles of chronic pain self-management to the workplace. Disabil Rehabil. 2012;34(8):694-703. doi: 10.3109/09638288.2011.615372. Epub 2011 Oct 17.
- Background: PubMed 23625029Shaw WS, Tveito TH, Boot CR. Introduction to the special section: sustainability of work with chronic health conditions. J Occup Rehabil. 2013 Jun;23(2):157-61. doi: 10.1007/s10926-013-9448-7.
- Derived from this study: PubMed 33983524Shaw WS, McLellan RK, Besen E, Namazi S, Nicholas MK, Dugan AG, Tveito TH. A Worksite Self-management Program for Workers with Chronic Health Conditions Improves Worker Engagement and Retention, but not Workplace Function. J Occup Rehabil. 2022 Mar;32(1):77-86. doi: 10.1007/s10926-021-09983-6. Epub 2021 May 13.
- Derived from this study: PubMed 24885844Shaw WS, Besen E, Pransky G, Boot CR, Nicholas MK, McLellan RK, Tveito TH. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions. BMC Public Health. 2014 May 28;14:515. doi: 10.1186/1471-2458-14-515.
- Individual participant dataSharing planned: Yes. De-identified data may be available to qualified researchers after data collection is complete
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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.
William S Shaw, Ph.D. principal investigator
Liberty Mutual Research Institute for Safety
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management group workshops in people with Chronic Physical Health Conditions, run by Liberty Mutual Research Institute for Safety at 4 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 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: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Work limitations (time frame: One year). The study lists 2 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 NCT01978392, which also lists 5 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 2 Jun 2017.