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Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05031767
Study type Interventional
Source Diakonhjemmet Hospital
Contact Nina Østerås, PhD
Phone 22451500
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date December 2023

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