- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06058949
Ochrana zdraví a podpora tlumočníků znakového jazyka prostřednictvím zavádění Total Worker Health®
Using mixed-methods and a clinical efficacy trial design, the overall objective of this study will employ implementation strategies to adapt and evaluate a previous integrated Total Worker Health® (TWH®) program and pilot test its efficacy on sign language interpreter well-being. The central hypothesis is that interpreters in the health protection and promotion program (intervention) will demonstrate significantly improved well-being compared to those in a general health program (control).
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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New York
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Rochester, New York, Spojené státy, 14642
- University of Rochester Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Bilingual in English and American Sign Language
- Certified sign language interpreter working at least 10 hours/week in any interpreter setting.
- Apparently healthy
Exclusion Criteria:
- Less than 18 year old
- Not yet certified as a sign language interpreter
- Unable to provide consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Program ochrany a podpory zdraví
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An adaptive integrated Total Worker Health® program. Virtual 8-week program that's been contextualized to the physical and mental health needs of sign language interpreters. It will examine biomechanics, sleep hygiene, vicarious trauma and burnout, demand-control schema, physical activity, emotional management strategies, proper nutrition and examination of worksite. |
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Aktivní komparátor: Obecný zdravotní program
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Virtual 8-week program that addresses participant sleep hygiene, physical activity and proper nutrition. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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mean change in acceptability using the Training Acceptability Rating Scale-1 (TARS-1)
Časové okno: 15 to 24 months
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TARS-1 measures acceptability using six items (1=strongly disagree; 6=strongly agree) and demonstrates good test-retest reliability, internal consistency, and construct and concurrent validity. The scale ranges from 6 to 36 with higher scores indicating better acceptability. |
15 to 24 months
|
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mean change in acceptability using the Training Acceptability Rating Scale-2 (TARS-2)
Časové okno: 15 to 24 months
|
TARS-2 assesses perceived impact with eight items (0=not at all; 3=a great deal) and demonstrates good face and concurrent validity. Of particular interest, TARS-2 also includes three qualitative items asking about the most helpful part of the program and any recommended changes and invites other comments. The scale ranges from 0-24 with higher scores indicating better outcomes. |
15 to 24 months
|
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mean change in Acceptability, Feasibility, and Appropriateness Scale
Časové okno: 15 to 24 months
|
This acceptability (six items), feasibility (three items), and appropriateness (five items) instrument will be used to assess whether or not the intervention efforts were successful. The 14 total items across three subscales demonstrate good to excellent internal consistency and are rated on a five-point scale (1=not at all; 5=extremely). High scores of 30, 15, and 25 and low scores of 6, 3, and 5 indicate excellent and poor acceptability, feasibility, and appropriateness, respectively. |
15 to 24 months
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience
Časové okno: baseline to post intervention (approximately 15-24 months)
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Work evaluation and experience is the first of five domains in this comprehensive measure of worker well-being and has 16 total questions. Total summed scores within this section range from 23-128 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to post intervention (approximately 15-24 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience
Časové okno: baseline to 6 months post intervention (approximately 21-30 months)
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Work evaluation and experience is the first of five domains in this comprehensive measure of worker well-being and has 16 total questions. Total scores within this section range from 23-128 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to 6 months post intervention (approximately 21-30 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture
Časové okno: baseline to post intervention (approximately 15-24 months)
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Workplace policies and culture is the second of five domains in this comprehensive measure of worker well-being and has 14 total questions. Total scores within this section range from 12-75 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to post intervention (approximately 15-24 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture
Časové okno: baseline to 6 months post intervention (approximately 21-30 months)
|
Workplace policies and culture is the second of five domains in this comprehensive measure of worker well-being and has 14 total questions. Total scores within this section range from 12-75 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to 6 months post intervention (approximately 21-30 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate
Časové okno: baseline to post intervention (approximately 15-24 months)
|
Workplace physical environment and safety climate is the third of five domains in this comprehensive measure of worker well-being and has 10 total questions. Total scores within this section range from 14-60 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to post intervention (approximately 15-24 months)
|
|
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate
Časové okno: baseline to 6 months post intervention (approximately 21-30 months)
|
Workplace physical environment and safety climate is the third of five domains in this comprehensive measure of worker well-being and has 10 total questions. Total scores within this section range from 14-60 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to 6 months post intervention (approximately 21-30 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status
Časové okno: baseline to post intervention (approximately 15-24 months)
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Health status is the fourth of five domains in this comprehensive measure of worker well-being and has 23 total questions. There are five open text box items within this section (i.e. asking for the number of days the respondent gets high intensity physical activity). Otherwise, total scores of the Likert scale items within this section range from 24-146 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to post intervention (approximately 15-24 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status
Časové okno: baseline to 6 months post intervention (approximately 21-30 months)
|
Health status is the fourth of five domains in this comprehensive measure of worker well-being and has 23 total questions. There are five open text box items within this section (i.e. asking for the number of days the respondent gets high intensity physical activity). Otherwise, total scores of the Likert scale items within this section range from 24-146 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to 6 months post intervention (approximately 21-30 months)
|
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mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society
Časové okno: baseline to post intervention (approximately 15-24 months)
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Home, community, and society is the final domain in this comprehensive measure of worker well-being and has 5 total questions. Total scores within this section range from 11-65 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to post intervention (approximately 15-24 months)
|
|
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society
Časové okno: baseline to 6 months post intervention (approximately 21-30 months)
|
Home, community, and society is the final domain in this comprehensive measure of worker well-being and has 5 total questions. Total scores within this section range from 11-65 with higher scores indicating better outcomes (accounting for inverse scoring on negative items). |
baseline to 6 months post intervention (approximately 21-30 months)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Eriksen HR, Ihlebaek C, Mikkelsen A, Gronningsaeter H, Sandal GM, Ursin H. Improving subjective health at the worksite: a randomized controlled trial of stress management training, physical exercise and an integrated health programme. Occup Med (Lond). 2002 Oct;52(7):383-91. doi: 10.1093/occmed/52.7.383.
- Tveito TH, Eriksen HR. Integrated health programme: a workplace randomized controlled trial. J Adv Nurs. 2009 Jan;65(1):110-9. doi: 10.1111/j.1365-2648.2008.04846.x. Epub 2008 Nov 14.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00008720
- K01OH012441 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
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