remote care in people with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: 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 (\ 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.

Eligibility criteria:
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

Keywords: remote care