Remote Monitoring of Axial Spondyloarthritis

NCT ID: NCT05031767

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2024-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care

Conventional current follow-up strategy

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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.

Remote monitoring

Remote monitoring by health professionals at the hospital

Group Type: EXPERIMENTAL

Remote monitoring

Intervention Type: OTHER

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 .

Patient-initiated care

No pre-scheduled visits or remote monitoring.

Group Type: EXPERIMENTAL

Patient-initiated care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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 .

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nina Osteras

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tore Kvien, MD, Professor em

Role: STUDY_CHAIR

Diakonhjemmet Hospital

Locations

Diakonhjemmet Hospital

Oslo, , Norway

Countries

Norway

References

Berg IJ, Tveter AT, Bakland G, Hakim S, Kristianslund EK, Lillegraven S, Macfarlane GJ, Moholt E, Provan SA, Sexton J, Thomassen EE, De Thurah A, Gossec L, Haavardsholm EA, Osteras N. Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial. JMIR Res Protoc. 2023 Dec 27;12:e52872. doi: 10.2196/52872.

Reference Type: DERIVED

PMID: 38150310 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

REK no.:229187

Identifier Type: -

Identifier Source: org_study_id