Making it Work Program for Systemic Sclerosis

Evaluation of the 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.

Study Overview

• Status: Completed
• Conditions: Scleroderma, Systemic
• Intervention / Treatment: Other: Making it Work Systemic Sclerosis

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Complete questionnaires Attend one 2 hour weekly virtual meeting for 5 weeks and an individual meeting with an occupational therapist and with a vocational counselor	Other: Making it Work Systemic Sclerosis; One 2 hour virtual meeting per week for 5 weeks, plus an individual meeting with an occupational therapist and a vocational counselor
No Intervention: control group; Complete questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Job Related Self-efficacy Scale	Measures self-efficacy for managing problems/challenges at work	baseline, 5 weeks, 12 weeks, 24 weeks
Job Self-Efficacy Scale	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	baseline, 5 weeks, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale	Measures absenteeism [secondary outcome; hours and days missed from work due to SSc] and presenteeism [secondary outcome; at-work productivity].	baseline, 5 weeks, 12 weeks, 24 weeks
The Work Instability Scale	Measures risk for future work loss	baseline, 5 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Janet L Poole, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): January 22, 2025

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: work
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 23-397

Drug and device information, study documents

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