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

Systemic Sclerosis Clinical Trial

— PRASSc  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05103553
• Other study ID #: P21.069
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2021
• Source: Leiden University Medical Center
• Contact: Jeska de Vries-Bouwstra, MD PhD
• Phone: +31(0)715263423
• Email: zorgpadsclerodermie[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Outpatient Clinic
Follow-up in outpatient clinic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Disease progression	Defined as progression in different organ systems.	Baseline, 6 months, 12 months, 18 months, 24 months
Secondary	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
Secondary	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
Secondary	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