Making it Work Program for Systemic Sclerosis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 67 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06338722
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of New Mexico
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janet L Poole
Principal Investigator Affiliation University of New Mexico
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scleroderma, Systemic
Arms & Interventions

Arms

Experimental: Intervention group

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

No Intervention: control group

Complete questionnaires

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of New Mexico, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico

Albuquerque, New Mexico, 87131-0001

Site Contact

Janet L Poole, PhD

[email protected]

505-272-8276