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

NCT05103553 | Unknown

• 1 other identifier: P21.069
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Sclerosis

Keywords

Prediction model; Systemic Sclerosis; Value based health care

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Disease progression

  Baseline, 6 months, 12 months, 18 months, 24 months

• health-related quality of life using 36-item short form survey (SF-36)

  Baseline, 6 months, 12 months, 18 months, 24 months

• health-related quality of life using EuroQol 5D (EQ5D)

  Baseline, 6 months, 12 months, 18 months, 24 months

• Illness perception using the validated instrument Brief Illness Perception Questionnaire (BIPQ )

  Baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (2)

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.

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.

Interventions

Outpatient Clinic OTHER

Follow-up in outpatient clinic

Annual screening at outpatient clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Jeska de Vries-Bouwstra, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeska de Vries-Bouwstra, MD PhD

CONTACT

+31(0)715263423; zorgpadsclerodermie@lumc.nl

Jessica A Vlot, MSc

CONTACT

+31(0)715263592; j.a.vlot@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. / Principal Investigator

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 2, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share