Making it Work Program for Systemic Sclerosis

NCT06338722 | Completed

• 1 other identifier: 23-397
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Systemic

Keywords

work

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale

  baseline, 5 weeks, 12 weeks, 24 weeks

• The Work Instability Scale

  baseline, 5 weeks, 12 weeks, 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

Complete questionnaires

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Janet L Poole

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: People will know what group they are in when they are invited to attend the intervention sessions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention receives the Making it work program Wait list Control receives usual care but will be offered the program after the intervention groups finish

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: April 1, 2024
• Study Start: December 8, 2023
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

US (1)