Remote monitoring in rheumatoid arthritis for early detection of flare, does remote patient-reported flare assessment agree with clinician flare assessment?

Remote Early Flare Detection for Rheumatoid Arthritis (REFDRA)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15980128

Enrollment

100

Registered

2019-10-28

Start date

2019-07-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis

Interventions

Remote data will be collected over a 12 month period using the Living With Rheumatoid Arthritis smartphone application, dynamometer and thermal camera (in a subset of patients). In addition to routine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Can access and operate an Android or iOS operating system smartphone or tablet device 2. Access to the internet 3. An active email account 4. Capacity to consent to participate in the study 5. Able to attend face-to-face appointments 3-monthly and within three days of onset of a flare 6. Able to complete the remote monitoring according to the documented schedule 7. English language proficiency to use the smartphone application and complete remote data entry

Exclusion criteria

Exclusion criteria: 1. Fibromyalgia syndrome (FMS). The symptomatology of this condition can be a source of confounding of patient-reported outcome measures (PROMs) in rheumatoid arthritis.

Design outcomes

Primary

Measure	Time frame
Agreement between patient assessment of flare (binary yes/no, reported in-app or in clinic) and a DAS28-CRP flare (yes/no) measured using Receiver Operator Curve (ROC) analysis. DAS28 flare is defined as an increase in DAS28 score of =1.2 from the most recent previous non-flare DAS28 score if it was <3.2, or an increase of =0.6 if the previous recorded non-flare DAS28 was =3.2. Agreement is defined as =0.7.	—

Measure

Time frame

Agreement between patient assessment of flare (binary yes/no, reported in-app or in clinic) and a DAS28-CRP flare (yes/no) measured using Receiver Operator Curve (ROC) analysis. DAS28 flare is defined as an increase in DAS28 score of =1.2 from the most recent previous non-flare DAS28 score if it was <3.2, or an increase of =0.6 if the previous recorded non-flare DAS28 was =3.2. Agreement is defined as =0.7.

—

Secondary

Measure	Time frame
1. Agreement between patient and clinician reporting of objective and patient-reported flare components. These components align with the Core Domain’s identified by the OMERACT group and encompass pain, physical function, fatigue, stiffness and participation. See omeract.org. 1.1 Clinician reported measures include: DAS 28-CRP and its constituent elements (28 tender joint count (TJC), 28 swollen joint count (SJC), physician global health assessment), and ultrasound assessment for joint synovitis (greyscale and Doppler). 1.2 Patient-reported measures include: patient-reported TJC and SJC, patient global health assessment, Routine Assessment of Patient Index Data 3 (RAPID3), the Health Assessment Questionnaire Disability Index (HAQ-DI), and grip strength (measured using a dynamometer in kg). 2. C-Reactive Protein (CRP) will be measured from blood drawn at time of clinical assessment, and a subset of patient will undergo thermal and photographic imaging of hands.	—

Measure

Time frame

1. Agreement between patient and clinician reporting of objective and patient-reported flare components. These components align with the Core Domain’s identified by the OMERACT group and encompass pain, physical function, fatigue, stiffness and participation. See omeract.org. 1.1 Clinician reported measures include: DAS 28-CRP and its constituent elements (28 tender joint count (TJC), 28 swollen joint count (SJC), physician global health assessment), and ultrasound assessment for joint synovitis (greyscale and Doppler). 1.2 Patient-reported measures include: patient-reported TJC and SJC, patient global health assessment, Routine Assessment of Patient Index Data 3 (RAPID3), the Health Assessment Questionnaire Disability Index (HAQ-DI), and grip strength (measured using a dynamometer in kg). 2. C-Reactive Protein (CRP) will be measured from blood drawn at time of clinical assessment, and a subset of patient will undergo thermal and photographic imaging of hands.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026