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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01978392
Other study ID # LMRIS 11-08
Secondary ID LMRIS Project 11
Status Completed
Phase N/A
First received November 1, 2013
Last updated June 1, 2017
Start date November 2013
Est. completion date May 31, 2017

Study information

Verified date June 2017
Source Liberty Mutual Research Institute for Safety
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date May 31, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Impending retirement or major career change (next 12 months).

- Not available to attend group workshops after working hours.

Study Design


Related Conditions & MeSH terms

  • Chronic Physical Health Conditions
  • Disease

Intervention

Behavioral:
Self-management group workshops
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.

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Hanover New Hampshire
United States Employer #4 (Confidential) Hanover New Hampshire
United States Employer #2 (confidential) Providence Rhode Island
United States Employer #3 (confidential) Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Liberty Mutual Research Institute for Safety

Country where clinical trial is conducted

United States, 

References & Publications (3)

Shaw 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. — View Citation

Shaw 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One year
Primary 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. One year
Secondary 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". One year
Secondary 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". One year
Secondary 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". One year
Secondary 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. One year
Secondary 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. One year
Secondary 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). One year
Secondary 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). One year