Clinical trial NCT06338722: Making it Work Program for Systemic Sclerosis
Official title: Evaluation of the Making it Work Program for Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma, Systemic
Keywords: work
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention receives the Making it work program Wait list Control receives usual care but will be offered the program after the intervention groups finish
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Job Related Self-efficacy Scale
timeFrame: baseline, 5 weeks, 12 weeks, 24 weeks
measure: Job Self-Efficacy Scale
timeFrame: baseline, 5 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale
timeFrame: baseline, 5 weeks, 12 weeks, 24 weeks
measure: The Work Instability Scale
timeFrame: baseline, 5 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Janet L Poole
role: PRINCIPAL_INVESTIGATOR
References: