systemic sclerosis, scleroderma
Conditions
Interventions
Based on a machine learning assisted prediction model (unpublished data of our
research group) the patients identified as low or intermediate risk profile for
disease progression are randomized in t
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all the following criteria: 1. Participation in the prospective Haga, HMC or LUMC cohort 2. Clinical diagnosis of SSc 3. Age of >=18 years 4. >= two evaluations in the Care Pathway. 5. Low or intermediate risk for disease progression according to the prediction model 6. Written informed consent for this study a. For participants in the Leiden University Medical Center: additional written informed consent for the Leiden CCISS cohort is required b. For participants in the Haga Hospital and Haaglanden Medical Center: sufficient data should be available to be able to calculate the risk score
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Patients with SSc who are part of ongoing (randomized) trials 2. Patients who have had an autologous stem cell transplantation in the past five years 3. Patients with SSc who were categorized as high risk for disease progression according to the predictive model.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary outcome measures: health care utilization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure: quality of life of SSc patients and patient*s satisfaction and perception of delivery care, and disease progression | — |
Countries
Netherlands
Contacts
Public ContactJ.K. de Vries - Bouwstra
Leids Universitair Medisch Centrum
Outcome results
None listed