Remote Care in People With Rheumatoid Arthritis

Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases

This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up compared to the conventional follow-up regimen with regular hospital visits.

The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups:

• Control group: conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month.
• Remote monitoring: monthly remote monitoring of PROs and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits.

Participants will be followed for 24 months. Primary outcome is proportionn maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up1.

• Structural: Assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space narrowing (0-168)), with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score <1 unit/year (<2 units from inclusion to 2-year follow-up).
• Functional: Measured by Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important3. Maintenance of functional treatment target is defined as a worsening <0.25 from inclusion to 2-year follow-up.
• Clinical: Measured by DAS28, categorized into remission (<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category.

We will use a 15% non-inferiority margin.

The study will comprise an internal pilot study the first 6 months for all participants in the intervention group.

The study will also include qualitative research including semi-structured interviews and observations of patients in the intervention group and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.

Inclusion Criteria:

• Male or non-pregnant, non-nursing female ≥18 years of age at screening
• Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)
• Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months
• Low disease activity or remission (CDAI<10 / DAS28<3.2) at inclusion
• <2 swollen joints
• Not deemed inappropriate for remote monitoring by the healthcare provider
• Capable of understanding and signing an informed consent form
• Access to a smartphone or tablet
• Able to speak and understand Norwegian language

Exclusion Criteria:

Medical conditions:

• Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
• Indications of active tuberculosis (TB)
• Treated with intravenous DMARD (e.g., rituximab and infliximab)

Diagnostic assessments:

• Abnormal renal function, defined as serum creatinine >142 µmol/L in female and >168 µmol/L in male, or glomerular filtration rate (GFR) <40 mL/min/1.73 m2
• Abnormal liver function (defined as Aspartate Transaminate (AST)/Alanine Transaminase (ALT) >3 x upper normal limit), active or recent hepatitis
• Leukopenia and/or thrombocytopenia

Other:

• Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
• Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.
• Deemed unsuitable for remote monitoring by medical doctor