Clinical trial NCT05031767: Remote Monitoring of Axial Spondyloarthritis
Official title: Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis
Keywords: rheumatic diseases
musculoskeletal diseases
joint diseases
arthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Low disease activity at follow-up
timeFrame: 6 months
measure: Low disease activity at follow-up
timeFrame: 12 months
measure: Low disease activity at follow-up
timeFrame: 18 months
Secondary outcomes:
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline, 6, 12 and 18 months
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Every month, maximum 18 months
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, 6, 12 and 18 months
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Every month, maximum 18 months
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, 3, 6, 9, 12, 15 and 18 months
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Every month, maximum 18 months
measure: C-Reactive Protein (CRP)
timeFrame: Every month, maximum 18 months
measure: Patient global assessment of disease activity
timeFrame: Baseline, 6, 12 and 18 months
measure: Patient global assessment of disease activity
timeFrame: Every month, maximum 18 months
measure: Patient global assessment of disease activity
timeFrame: 3, 6, 9, 12, 15 and 18 months
measure: Patient-reported flare
timeFrame: 6, 12 and 18 months
measure: Patient-reported flare
timeFrame: Every month, maximum 18 months
measure: Patient-reported flare
timeFrame: 3, 6, 9, 12, 15 and 18 months
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, 6, 12 and 18 months
measure: Activity Impairment
timeFrame: Baseline, 6, 12 and 18 months
measure: Patient-reported global change in disease activity
timeFrame: 6, 12 and 18 months
measure: Patient-reported global change in activity impairment
timeFrame: 6, 12 and 18 months
measure: Pain (general)
timeFrame: Baseline, 6, 12 and 18 months
measure: Joint pain
timeFrame: Baseline, 6, 12 and 18 months
measure: Sleep impairment
timeFrame: Baseline, 6, 12 and 18 months
measure: Patient satisfaction with care
timeFrame: Baseline, 6, 12 and 18 months
measure: Daily steps
timeFrame: Through study completion, maximum 18 months
measure: Mean pulse level
timeFrame: Through study completion, maximum 18 months
measure: Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)
timeFrame: Baseline, 6, 12 and 18 months
measure: Concomitant medication
timeFrame: Baseline, 6, 12 and 18 months
measure: Swollen joint count
timeFrame: Baseline, 6, 12 and 18 months
measure: Swollen joint count
timeFrame: Baseline, through study completion, and 18 months
measure: Tender joint count
timeFrame: Baseline, 6, 12 and 18 months
measure: Tender joint count
timeFrame: Baseline, through study completion, and 18 months
measure: Heel enthesitis
timeFrame: Baseline, 6, 12 and 18 months
measure: Heel enthesitis
timeFrame: Baseline, through study completion, and 18 months
measure: Costs related to hospital visits
timeFrame: Baseline
measure: Costs related to hospital visits
timeFrame: Baseline
measure: The need to take time off work for hospital visits or video consultations
timeFrame: Baseline
measure: Health care utilization
timeFrame: Baseline, 6, 12 and 18 months
measure: Extra visits, telephone and video consultations
timeFrame: Through study completion, maximum 18 months
measure: Withdrawals/Early discontinuation
timeFrame: Through study completion, maximum 18 months
measure: Adverse events
timeFrame: Through study completion, maximum 18 months
measure: Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale
timeFrame: Baseline
measure: eHealth literacy
timeFrame: Baseline
measure: Body signs and symptoms
timeFrame: 18 months
measure: Patient satisfaction with remote monitoring or patient-initiated care
timeFrame: 18 months
measure: Patient satisfaction with remote monitoring or patient-initiated care
timeFrame: 18 months
measure: Preferred follow-up strategy
timeFrame: 18 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Tore Kvien, MD, Professor em
role: STUDY_CHAIR
References: