Remote monitoring in rheumatoid arthritis

Not Applicable

Completed

Conditions: Rheumatoid arthritis
Musculoskeletal Diseases

Registration Number: ISRCTN25879022

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 13

Inclusion Criteria

1. Diagnosis of rheumatoid arthritis according to the 1987 American College of Rheumatology (ACR) or 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria applied at any time since diagnosis.
2. Participant about to commence (i.e. planned within next 4 weeks), or recently commenced (i.e. within past 8 weeks), a new disease-modifying anti-rheumatic drug (i.e. conventional synthetic DMARD, Janus-kinase inhibitor or biologic therapy)
3. Able to walk at least four metres independently without walking aids
4. Participant willing to commit to complete remote monitoring measurements and wear monitoring devices

Exclusion Criteria

1. Unable to read or communicate in English
2. Current participation within an interventional clinical trial (participation in another observational trial is permitted)
3. Inability to provide informed consent
4. Age less than 18 years
5. Current diagnosis of a movement disorder
6. Current pregnancy

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Arthritis activity measured using the disease activity score in 28 joints (DAS28) score at baseline, week 4, week 8 and week 12.<br>2. Arthritis activity measured using the rheumatoid arthritis disease activity index 5 (RADAI-5) at baseline, week 4, week 8 and week 12

Secondary Outcome Measures

Name	Time	Method
1. Physical activity measured by Axivity AX6 devices at baseline, week 4, week 8 and week 12<br>2. Cardiorespiratory activity measured by VitalPatch devices at baseline, week 4, week 8 and week 12<br>3. Fatigue measured by the FACIT-F questionnaire at baseline, week 4, week 8 and week 12<br>4. Fatigue measured by the MFS questionnaire at baseline, week 4, week 8 and week 12<br>5. Physical function measured by the HAQ-DI questionnaire at baseline, week 4, week 8 and week 12<br>6. Anxiety and depression measured by the PHQ-2 questionnaire at baseline, week 4, week 8 and week 12<br>7. General health measured by the EQ-5D-5L questionnaire at baseline, week 4, week 8 and week 12