Psychometric Properties of the Cristal Pro Through an Online Registry

Overview

About this study

The purpose of this study is to validate the CRISTAL patient-reported outcome (PRO) where patients will complete PROs at baseline and again at 6 months. The PRO includes survey items designed to assess limited cutaneous systemic sclerosis (lcSSc) symptoms and experiences from a patient perspective. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥18.
  • A diagnostic of limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma by a physician according to LeRoy and Medsger criteria.
  • With any disease duration.
  • Fulfilling the 2013 ACR/EULAR classification criteria for SSc.
  • Receiving care in one of the recruiting centers.
  • We encourage the inclusion of patients who are starting new medications or experiencing an escalation of their current medications for SSc-related symptoms at the time of the entry in the registry/inclusion visit.

Exclusion Criteria:

  • Unable to read English.
  • Lack of computer or smart device such as smartphone.
  • Any past history of diffuse cutaneous systemic sclerosis.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/31/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vivek Nagaraja, M.B.B.S., M.D.

Contact us for the latest status

Contact information:

Vivek Nagaraja M.B.B.S., M.D.

Nagaraja.Vivek@mayo.edu

More information

Publications

Publications are currently not available