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

Sponsor

Leiden University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05103553

Collaborator

(none)

250

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Other: Outpatient Clinic	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Health care utilization Baseline [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.
Health care utilization after 6 months [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.
Health care utilization after 12 months [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.
Health care utilization after 18 months [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.
Health care utilization after 24 months [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.

Secondary Outcome Measures

Disease progression [Baseline, 6 months, 12 months, 18 months, 24 months]
Defined as progression in different organ systems.
health-related quality of life using 36-item short form survey (SF-36) [Baseline, 6 months, 12 months, 18 months, 24 months]
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Rely upon patient self-reporting.
health-related quality of life using EuroQol 5D (EQ5D) [Baseline, 6 months, 12 months, 18 months, 24 months]
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.
Illness perception using the validated instrument Brief Illness Perception Questionnaire (BIPQ ) [Baseline, 6 months, 12 months, 18 months, 24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participation in the prospective Haga, HMC or LUMC cohort
Clinical diagnosis of SSc
Age of ≥18 years
= two evaluations in the Care Pathway
Low or intermediate risk for disease progression according to the prediction model
Written informed consent

Exclusion Criteria:

Patients with SSc who are part of ongoing (randomized) trials
Patients who have had an autologous stem cell transplantation in the past five years
Patients with SSc who were categorized as high risk for disease progression according to the prediction model.