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

NCT ID: NCT05103553

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-01-01

Brief Summary

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.

Detailed 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.

Conditions

Systemic Sclerosis

Keywords

Prediction model; Systemic Sclerosis; Value based health care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Annual screening at outpatient clinic

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.

Group Type: EXPERIMENTAL

Outpatient Clinic

Intervention Type: OTHER

Follow-up in outpatient clinic

Annual screening at Care Pathway Systemic Sclerosis

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Outpatient Clinic

Follow-up in outpatient clinic

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeska K. de Vries-Bouwstra

Dr. / Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeska de Vries-Bouwstra, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Central Contacts

Jeska de Vries-Bouwstra, MD PhD

Role: CONTACT

Phone: +31(0)715263423

Email: zorgpadsclerodermie@lumc.nl

Jessica A Vlot, MSc

Role: CONTACT

Phone: +31(0)715263592

Email: j.a.vlot@lumc.nl

Other Identifiers

P21.069

Identifier Type: -

Identifier Source: org_study_id