NCT06058949

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress86%
May 2024Aug 2026

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

September 21, 2023

Last Update Submit

February 4, 2026

Conditions

Keywords

sign language interpretersTotal Worker Health®

Outcome Measures

Primary Outcomes (13)

  • 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)

Study Arms (2)

Health Protection and Promotion Program

EXPERIMENTAL
Behavioral: Health Protection and Promotion

General Health Program

ACTIVE COMPARATOR
Behavioral: General Health Program

Interventions

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.

Health Protection and Promotion Program

Virtual 8-week program that addresses participant sleep hygiene, physical activity and proper nutrition.

General Health Program

Eligibility Criteria

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

You may qualify if:

  • Bilingual in English and American Sign Language
  • Certified sign language interpreter working at least 10 hours/week in any interpreter setting.
  • Apparently healthy

You may not qualify if:

  • Less than 18 year old
  • Not yet certified as a sign language interpreter
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (2)

  • 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.

    PMID: 12422025BACKGROUND
  • 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.

    PMID: 19032505BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

May 1, 2024

Primary Completion

February 28, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations