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

Value Based Health Care in Systemic Sclerosis: What is the Optimal Follow-up for Patients With Systemic Sclerosis?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: Outpatient Clinic

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeska de Vries-Bouwstra, MD PhD; Phone Number: +31(0)715263423; Email: zorgpadsclerodermie@lumc.nl
• Study Contact Backup: Name: Jessica A Vlot, MSc; Phone Number: +31(0)715263592; Email: j.a.vlot@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Outpatient Clinic; Follow-up in outpatient clinic
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization Baseline	Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted.	Baseline
Health care utilization after 6 months	Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted.	6 months
Health care utilization after 12 months	Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted.	12 months
Health care utilization after 18 months	Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted.	18 months
Health care utilization after 24 months	Includes different health-care services: rheumatologist, other medical specialists, General Practioner (GP), health professionals, hospital admission, hospital based day-care. Number of contacts/visits within previous 6 months will be counted.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Defined as progression in different organ systems.	Baseline, 6 months, 12 months, 18 months, 24 months
health-related quality of life using 36-item short form survey (SF-36)	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Rely upon patient self-reporting.	Baseline, 6 months, 12 months, 18 months, 24 months
health-related quality of life using EuroQol 5D (EQ5D)	comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. each dimension has 5 levels varying from no problems until extreme problems. Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.The EQ visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's judgement.	Baseline, 6 months, 12 months, 18 months, 24 months
Illness perception using the validated instrument Brief Illness Perception Questionnaire (BIPQ )	A nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. Each question is be answered with a number on a scale of 0 until 10.	Baseline, 6 months, 12 months, 18 months, 24 months

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Jeska de Vries-Bouwstra, MD PhD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Systemic Sclerosis; Prediction model; Value based health care
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: P21.069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No