Clinical trial NCT05103553: What is the Optimal Follow-up for Patients With Systemic Sclerosis?
Official title: Value Based Health Care in Systemic Sclerosis: What is the Optimal Follow-up for Patients With Systemic Sclerosis?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Systemic Sclerosis
Keywords: Prediction model
Systemic Sclerosis
Value based health care
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Health care utilization Baseline
timeFrame: Baseline
measure: Health care utilization after 6 months
timeFrame: 6 months
measure: Health care utilization after 12 months
timeFrame: 12 months
measure: Health care utilization after 18 months
timeFrame: 18 months
measure: Health care utilization after 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Disease progression
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: health-related quality of life using 36-item short form survey (SF-36)
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: health-related quality of life using EuroQol 5D (EQ5D)
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Illness perception using the validated instrument Brief Illness Perception Questionnaire (BIPQ )
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Jeska de Vries-Bouwstra, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: