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

NCT07740200 | Completed DMC

• 1 other identifier: 1910/Synovo/NIS/25
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

DDAS; Synovo; tele-rheumatology; digital health; joint movement analysis; smartphone video assessment; remote patient monitoring; digital assessment; DAS28; disease activity assessment; Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Correlation Between DDAS and Clinician-Derived DAS28

  Pearson correlation coefficient between paired Synovo Digital Disease Activity Score and clinician-derived DAS28 values, reported with a 95% confidence interval.

  At each paired assessment during the same clinical encounter.

Secondary Outcomes (1)

• Numerical Agreement Between DDAS and DAS28

  At each paired assessment during the same clinical encounter.

Other Outcomes (1)

• Longitudinal Change in Disease Activity

  Between consecutive paired assessments, approximately 1 week to 7 months.

Study Arms (1)

Rheumatoid Arthritis Cohort

Adults with rheumatoid arthritis undergoing a Synovo digital disease activity assessment and a clinician-administered DAS28 assessment during the same visit. Some participants completed repeat paired assessments at follow-up visits.

Device: Digital Disease Activity Assessment

Interventions

Digital Disease Activity Assessment DEVICE

Participants completed a structured digital questionnaire and recorded guided smartphone videos of selected joint movements. The resulting digital disease activity score was compared with the clinician-administered DAS28 score.

Also known as: DDAS28, DDAS

Rheumatoid Arthritis Cohort

Eligibility Criteria

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

Study Population

Adults with clinician-confirmed rheumatoid arthritis receiving routine outpatient care at Aap Ka Clinic in Lahore, Pakistan. Participants were identified through the clinic's existing rheumatoid arthritis patient population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synovo Ltd.: lead
• Aap Ka Clinic: collaborator
• Akram Medical Complex: collaborator

Study Sites (1)

Aap Ka Clinic

Lahore, Punjab Province, Pakistan

Location

Related Publications (4)

• Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.

  PMID: 17613642 RESULT

• Creagh AP, Hamy V, Yuan H, Mertes G, Tomlinson R, Chen WH, Williams R, Llop C, Yee C, Duh MS, Doherty A, Garcia-Gancedo L, Clifton DA. Digital health technologies and machine learning augment patient reported outcomes to remotely characterise rheumatoid arthritis. NPJ Digit Med. 2024 Feb 12;7(1):33. doi: 10.1038/s41746-024-01013-y.

  PMID: 38347090 RESULT

• Nishiguchi S, Ito H, Yamada M, Yoshitomi H, Furu M, Ito T, Shinohara A, Ura T, Okamoto K, Aoyama T. Self-assessment tool of disease activity of rheumatoid arthritis by using a smartphone application. Telemed J E Health. 2014 Mar;20(3):235-40. doi: 10.1089/tmj.2013.0162. Epub 2014 Jan 3.

  PMID: 24404820 RESULT

• Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.

  PMID: 7818570 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Founder, Synovo

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: October 24, 2025
• Primary Completion: July 10, 2026
• Study Completion: July 10, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

PA (1)