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MANAGE AT WORK: Addressing the Challenge of Chronic Physical Health Conditions in the Workplace

1. června 2017 aktualizováno: Liberty Mutual Research Institute for Safety

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

122

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Massachusetts
      • Worcester, Massachusetts, Spojené státy
        • Employer #3 (confidential)
    • New Hampshire
      • Hanover, New Hampshire, Spojené státy, 03755
        • Dartmouth-Hitchcock Medical Center
      • Hanover, New Hampshire, Spojené státy, 03755
        • Employer #4 (Confidential)
    • Rhode Island
      • Providence, Rhode Island, Spojené státy
        • Employer #2 (confidential)

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Self-management group workshops
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.
Behaviorální: 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.
Žádný zásah: No treament (wait-list control)
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Work limitations
Časové okno: 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.
One year
Work engagement
Časové okno: 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.
One year

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Work fatigue
Časové okno: One year
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
Turnover intention
Časové okno: One year
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
Job satisfaction
Časové okno: One year
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
Self-efficacy
Časové okno: One year
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
General health status
Časové okno: One year
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
Sickness absence
Časové okno: One year
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
Healthcare utilization
Časové okno: One year
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Liberty Mutual Research Institute for Safety

Vyšetřovatelé

  • Vrchní vyšetřovatel: William S Shaw, Ph.D., Liberty Mutual Research Institute for Safety

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2013

Primární dokončení (Aktuální)

31. května 2017

Dokončení studie (Aktuální)

31. května 2017

Termíny zápisu do studia

První předloženo

1. listopadu 2013

První předloženo, které splnilo kritéria kontroly kvality

6. listopadu 2013

První zveřejněno (Odhad)

7. listopadu 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. června 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. června 2017

Naposledy ověřeno

1. června 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • LMRIS 11-08
  • LMRIS Project 11-08 (Jiné číslo grantu/financování: Liberty Mutual Research Institute for Safety)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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