NCT01978392

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

3.6 years

First QC Date

November 1, 2013

Last Update Submit

June 1, 2017

Conditions

Keywords

disabilityself-managementchronic illnesschronic painoccupation> 6 months

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Work fatigue

    One year

  • Turnover intention

    One year

  • Job satisfaction

    One year

  • Self-efficacy

    One year

  • General health status

    One year

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Self-management group workshops

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Impending retirement or major career change (next 12 months).
  • Not available to attend group workshops after working hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Employer #3 (confidential)

Worcester, Massachusetts, United States

Location

Dartmouth-Hitchcock Medical Center

Hanover, New Hampshire, 03755, United States

Location

Employer #4 (Confidential)

Hanover, New Hampshire, 03755, United States

Location

Employer #2 (confidential)

Providence, Rhode Island, United States

Location

Related Publications (5)

  • 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.

    PMID: 20860528BACKGROUND
  • 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.

    PMID: 22004668BACKGROUND
  • 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.

    PMID: 23625029BACKGROUND
  • Shaw 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.

  • Shaw 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.

MeSH Terms

Conditions

Chronic DiseaseChronic Pain

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • William S Shaw, Ph.D.

    Liberty Mutual Research Institute for Safety

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 7, 2013

Study Start

November 1, 2013

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

De-identified data may be available to qualified researchers after data collection is complete

Locations