Scleroderma, SystemicNCT06338722
Making it Work Program for Systemic Sclerosis
A study testing Making it Work Systemic Sclerosis in people with Scleroderma, Systemic, run by University of New Mexico at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Making it Work Systemic Sclerosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2023to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131-0001
About this study
Official title: 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.
- Conditions
- Scleroderma, Systemic
- Being tested
- Making it Work Systemic Sclerosis
- Keywords
- work
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making it Work Systemic SclerosisOther
One 2 hour virtual meeting per week for 5 weeks, plus an individual meeting with an occupational therapist and a vocational counselor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Making it Work Systemic Sclerosis |
| control group | No intervention | Complete questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Job Related Self-efficacy Scale
Measures self-efficacy for managing problems/challenges at work
Measured: 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
Measured: baseline, 5 weeks, 12 weeks, 24 weeks
Secondary outcomes (2)
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].
Measured: baseline, 5 weeks, 12 weeks, 24 weeks
The Work Instability Scale
Measures risk for future work loss
Measured: baseline, 5 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start8 Dec 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet L Poole, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338722
- Sponsor's protocol ID
- 23-397
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Making it Work Program for Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06338722
- Acronym / sponsor ID
- 23-397
- Conditions
- Scleroderma, Systemic
- Keywords
- work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Making it Work Systemic SclerosisComplete questionnaires Attend one 2 hour weekly virtual meeting for 5 weeks and an individual meeting with an occupational therapist and with a vocational counselor |
| control group | No intervention | –Complete questionnaires |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Making it Work Systemic SclerosisOne 2 hour virtual meeting per week for 5 weeks, plus an individual meeting with an occupational therapist and a vocational counselor | Other | Intervention group |
Primary outcome
Job Related Self-efficacy Scale
Time frame: baseline, 5 weeks, 12 weeks, 24 weeks
Measures self-efficacy for managing problems/challenges at work
Job Self-Efficacy Scale
Time frame: 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
2 secondary outcomes
Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale
Time frame: baseline, 5 weeks, 12 weeks, 24 weeks
The Work Instability Scale
Time frame: baseline, 5 weeks, 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet L Poole principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making it Work Systemic Sclerosis in people with Scleroderma, Systemic, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Job Related Self-efficacy Scale (time frame: baseline, 5 weeks, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.