Making it Work Program for Systemic Sclerosis

Scleroderma, Systemic Clinical Trial

Official title:

Evaluation of the Making it Work Program for Systemic Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338722
• Other study ID #: 23-397
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: Janet L Poole, PhD
• Phone: 5053319551
• Email: jpoole[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Job Related Self-efficacy Scale	Measures self-efficacy for managing problems/challenges at work	baseline, 5 weeks, 12 weeks, 24 weeks
Primary	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	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
Secondary	The Work Instability Scale	Measures risk for future work loss	baseline, 5 weeks, 12 weeks, 24 weeks