Making it Work Program for Systemic Sclerosis

Not Applicable

Completed

• Conditions: Scleroderma, Systemic
• Interventions: Other: Making it Work Systemic Sclerosis

• Registration Number: NCT06338722
• Lead Sponsor: University of New Mexico

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-08
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-01
• Primary Completion: 2025-01-22
• Study Completion: 2025-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Making it Work Systemic Sclerosis	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

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States