Health Protection and Promotion of Sign Language Interpreters Through Implementation of 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Well-Being, Psychological
• Intervention / Treatment: Behavioral: Health Protection and Promotion; Behavioral: General Health Program

• Study Type: Interventional
• Enrollment (Estimated): 133
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gretchen Roman, PT, DPT, PhD; Phone Number: 585-324-4568; Email: gretchen_roman@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
      • Contact: Gretchen Roman, PT, DPT, PhD; Email: gretchen_roman@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Protection and Promotion Program	Behavioral: Health Protection and Promotion; 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.
Active Comparator: General Health Program	Behavioral: General Health Program; Virtual 8-week program that addresses participant sleep hygiene, physical activity and proper nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change in acceptability using the Training Acceptability Rating Scale-1 (TARS-1)	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
mean change in acceptability using the Training Acceptability Rating Scale-2 (TARS-2)	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
mean change in Acceptability, Feasibility, and Appropriateness Scale	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
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- work evaluation and experience	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace policies and culture	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- workplace physical environment and safety climate	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	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- health status	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)
mean change in the National Institute of Occupational Safety and Health's Worker Well-Being Questionnaire- home, community, and society	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	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)

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Centers for Disease Control and Prevention

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: sign language interpreters; Total Worker Health®
• Other Study ID Numbers: STUDY00008720; K01OH012441 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No