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Validation of the Synovo Digital Disease Activity Score (DDAS) Against Physician-Performed DAS28/CDAI: A Non-Clinical, Non-Interventional, Non-Academic Study
Validation of the Synovo Digital Disease Activity Score (DDAS) Against Physician-Performed DAS28/CDAI: A Non-Clinical, Non-Interventional, Non-Academic Study

NCT07740200

CompletedN/A

Sponsor: Synovo Ltd.

Conditions: Rheumatoid Arthritis (RA)

Interventions: Digital Disease Activity Assessment

Countries: Pakistan

The goal of this observational study is to assess whether the Synovo digital assessment can measure rheumatoid arthritis disease activity in adults with rheumatoid arthritis. The main questions it aims to answer are: How closely does the Synovo digital disease activity score agree with the clinician-assessed DAS28 score? Can the Synovo assessment identify changes in disease activity between follow-up visits? Participants will: Complete a structured digital questionnaire Record guided videos of selected joint movements using a smartphone Undergo a standard DAS28 assessment by a clinician during the same visit Some participants may repeat the assessments at a later follow-up visit.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria

* Age 18 years or older
* Any sex or gender
* Clinician-confirmed rheumatoid arthritis, consistent with established ACR/EULAR criteria or a documented routine-care diagnosis
* Receiving routine care at Aap Ka Clinic during the study period
* Able and willing to provide written informed consent
* Able to complete the DDAS assessment independently or with reasonable non-clinical assistance
* Access to a compatible smartphone or tablet and sufficient connectivity for video upload

Exclusion Criteria

* Younger than 18 years
* Unable to provide informed consent
* A non-rheumatoid condition that substantially prevents completion or interpretation of the guided movements
* Unable to complete study procedures despite reasonable assistance
* Concurrent participation in another interventional study where participation could affect the reference or index assessments
Locations (1)
  • Lahore, Punjab Province, Pakistan