What is the Optimal Follow-up for Patients With Systemic Sclerosis? (PRASSc)

Leiden University Medical Center (LUMC)

Status: Not yet enrolling

Conditions: Systemic Sclerosis

Treatments: Other: Outpatient Clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT05103553

P21.069

Details and patient eligibility

About

Systemic sclerosis (SSc) is a complex multisystem rheumatic autoimmune disease. Currently, evidence based guidelines for frequency and intensity of follow-up of SSc patients are not available. Based on expert consensus annual extensive evaluation is recommended. To provide comprehensive multidisciplinary care integrated with evaluation of organ involvement and as such, reducing health care utilization while improving the quality of care for the patient, the "Leiden Combined Care in SSc (CCISS) pathway" was started in 2009. Data collected on disease progression in the patients that participate in this care pathway show that 50% of the patients have relatively mild disease, without any disease progression over time. Therefore there is a need for tailor made care in SSc patients in accordance to disease activity. To enable this, a prediction model was developed that can identify patients with low risk for disease progression.

Full description

Objectives: To evaluate in SSc patients with low risk for disease progression 1) whether assessment in an outpatient clinic setting is an acceptable alternative for evaluation in the Care Pathway. Outcome parameters we will evaluate include 1) health care utilization, 2) patients' perception of the disease and delivery of care, 3) health-related quality of life and 4) disease progression. Health care utilization as primary outcome is defined as number of contacts with heath care providers during 12 months.

Study population: Patients with a clinical diagnosis of SSc that participated in the Combined Care in Systemic Sclerosis cohort from Leiden University Medical Center (LUMC), or in the comparable care pathway of the Haga hospital and Haaglanden Medical Center (HMC), and that have had at least two care pathway evaluations are eligible to participate in this study.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

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 prediction model.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Annual screening at outpatient clinic

Experimental group

Description:

After signing informed consent, patients with low risk for disease progression (in the low or intermediate risk group) wil be randomized into the intervention group (annual assessment at the outpatient clinic). Due to the nature of the intervention, the randomization will not be blinded, as this is not possible.

Treatment:

Other: Outpatient Clinic

Annual screening at Care Pathway Systemic Sclerosis

No Intervention group

Description:

After signing informed consent, patients with low risk for disease progression (in the low or intermediate risk group) will be randomized into the control group (annual assessment at the care pathway). Due to the nature of the intervention, the randomization will not be blinded, as this is not possible.