Systemic SclerosisPRASScNCT05103553
What is the Optimal Follow-up for Patients With Systemic Sclerosis?
A study testing Outpatient Clinic in people with Systemic Sclerosis, run by Leiden University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Outpatient Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Outpatient Clinic
- Keywords
- Prediction model, Systemic Sclerosis, Value based health care
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient ClinicOther
Follow-up in outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| Annual screening at outpatient clinic | Experimental | 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. Receives: Other: Outpatient Clinic |
| Annual screening at Care Pathway Systemic Sclerosis | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (4)
Disease progression
Defined as progression in different organ systems.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeska K. de Vries-Bouwstra, Leiden University Medical Center
- Investigators
- Jeska de Vries-Bouwstra, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103553
- Sponsor's protocol ID
- P21.069
- Acronym
- PRASSc
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoekstra EM, Liem SIE, Ahmed S, Dijkman LD, van der Wouden KE, van Leeuwen NM, Hortensius-Varkevisser AM, van der Lans SE, Voorde LJJB, Dongen HG, Knevel R, Huizinga TWJ, Schouffoer AA, de Vries-Bouwstra JK. Exploring the optimal follow-up for systemic sclerosis patients: study protocol for a Dutch multicenter randomized controlled trial. Trials. 2026 Feb 14;27(1):221. doi: 10.1186/s13063-026-09494-w.
PubMed 41689135
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value Based Health Care in Systemic Sclerosis: What is the Optimal Follow-up for Patients With Systemic Sclerosis?
- ClinicalTrials.gov ID
- NCT05103553
- Acronym / sponsor ID
- PRASSc / P21.069
- Conditions
- Systemic Sclerosis
- Keywords
- Prediction model, Systemic Sclerosis, Value based health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Annual screening at outpatient clinic | Experimental | Other: Outpatient ClinicAfter 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. |
| Annual screening at Care Pathway Systemic Sclerosis | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient ClinicFollow-up in outpatient clinic | Other | Annual screening at outpatient clinic |
Primary outcome
Health care utilization Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Disease progression
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
health-related quality of life using 36-item short form survey (SF-36)
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
health-related quality of life using EuroQol 5D (EQ5D)
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Illness perception using the validated instrument Brief Illness Perception Questionnaire (BIPQ )
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 41689135Hoekstra EM, Liem SIE, Ahmed S, Dijkman LD, van der Wouden KE, van Leeuwen NM, Hortensius-Varkevisser AM, van der Lans SE, Voorde LJJB, Dongen HG, Knevel R, Huizinga TWJ, Schouffoer AA, de Vries-Bouwstra JK. Exploring the optimal follow-up for systemic sclerosis patients: study protocol for a Dutch multicenter randomized controlled trial. Trials. 2026 Feb 14;27(1):221. doi: 10.1186/s13063-026-09494-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeska de Vries-Bouwstra, MD PhD principal investigator
Leiden University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Clinic in people with Systemic Sclerosis, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeska de Vries-Bouwstra, MD PhD (+31(0)715263423, zorgpadsclerodermie@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care utilization Baseline (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.