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Completed

NCT Number: NCT06338722

Making it Work Program for Systemic Sclerosis

The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis.

Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better.

People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time.

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Key information

Conditions

Scleroderma, Systemic Connective Tissue Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently employed (full-time, part-time)
  • Over 18 and less than or equal to 67 years of age
  • Reside and work in the United States
  • Self-report diagnosis with systemic sclerosis (scleroderma; systemic sclerosis)
  • Report concerns about risk for job loss
  • Possess sufficient spoken English to participate in a group
  • Have device with audio and visual videoconferencing capabilities
  • Be willing to participate in a 2.0 hour virtual meeting once a week for 5 weeks
  • Be willing to complete assigned pre-meeting worksheets
  • Be willing to meet virtually with both an occupational therapist and vocational counselor after the 5th weekly sessin.

Exclusion criteria

  • Not working (full-time, part-time, self-employed, contract work)
  • Pregnant
  • Less than 18 and over 67 years of age
  • Do not work in the United States
  • Do not report are not concerned about job loss
  • Do not have a device with audio and visual videoconferencing capabilities
  • Do note communicate sufficiently in English
  • Are not able to participate in the program for 5 weeks
  • Are not wiling to complete pre-meeting worksheets
  • Not willing to meet with both an occupational therapist and vocational counselor.

Treatment and study plan

Making it Work Systemic Sclerosis

Other

One 2 hour virtual meeting per week for 5 weeks, plus an individual meeting with an occupational therapist and a vocational counselor

Primary outcomes

  1. Job Related Self-efficacy Scale

    Time frame: baseline, 5 weeks, 12 weeks, 24 weeks

    Measures self-efficacy for managing problems/challenges at work

  2. Job Self-Efficacy Scale

    Time frame: baseline, 5 weeks, 12 weeks, 24 weeks

    Measures confidence in concepts targeted by the Making it Work Program such as disease management at work, stress management, ability to communicate effectively, obtaining job accommodations

Secondary outcomes

  1. Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale

    Time frame: baseline, 5 weeks, 12 weeks, 24 weeks

    Measures absenteeism [secondary outcome; hours and days missed from work due to SSc] and presenteeism [secondary outcome; at-work productivity].

  2. The Work Instability Scale

    Time frame: baseline, 5 weeks, 12 weeks, 24 weeks

    Measures risk for future work loss

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Evaluation of the Making it Work Program for Systemic Sclerosis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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