NCT05031767

Remote Monitoring of Axial Spondyloarthritis

Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Diakonhjemmet Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
OTHER	Usual care	Conventional follow-up strategy with blood tests, patient-reported outcomes, and pre-scheduled visits at the hospital every 6th month. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital.
OTHER	Remote monitoring	Hospital health professionals perform remote monitoring of frequent patient-reported outcomes, blood test results, and physical activity data available on a digital platform. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital .
OTHER	Patient-initiated care	No pre-scheduled visits or remote monitoring. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital.

Timeline

• Start date: 2021-09-07
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2021-09-02
• Last updated: 2024-02-29

Locations

1 site across 1 country: Norway