Remote Monitoring of Axial Spondyloarthritis (ReMonit)

Diakonhjemmet Hospital

Status: Completed

Conditions: Axial Spondyloarthritis

Treatments: Other: Remote monitoring; Other: Patient-initiated care; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05031767

REK no.:229187

Details and patient eligibility

About

The ReMonit study is a 18-months, non-inferiority randomized, controlled trial with three parallel arms to determine if two, new follow-up strategies for patients with axial spondyloarthritis (axSpA) are non-inferior in maintaining stable, low disease activity over time compared to the conventional follow-up regimen with regular hospital visits.

Full description

The trial will include Norwegian adult males and females with axial spondyloarthritis.

240 participants will be randomized 1:1:1 to either:

1. Control group: a. Usual care, i.e. conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month
2. Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform
3. Patient-initiated care: no pre-scheduled visits or remote monitoring

The study has 18 months follow-up. We will use a 15% non-inferiority margin.

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

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant, non-nursing female >18 years of age at screening
• Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
• Stable medical treatment with TNFi the last 6 months
• Low disease activity (ASDAS<2.1) at inclusion
• Capable of understanding the Norwegian language and of signing an informed consent form

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)

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 Alanine Transaminase (ALT) >3x 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 3 patient groups

Usual care

Active Comparator group

Description:

Conventional current follow-up strategy

Treatment:

Other: Usual care

Remote monitoring

Experimental group

Description:

Remote monitoring by health professionals at the hospital

Treatment:

Other: Remote monitoring

Patient-initiated care

Experimental group

Description:

No pre-scheduled visits or remote monitoring.

Treatment:

Other: Patient-initiated care