Remote Monitoring of Axial Spondyloarthritis
- Conditions
- Axial Spondyloarthritis
- Interventions
- Other: Usual careOther: Patient-initiated careOther: Remote monitoring
- Registration Number
- NCT05031767
- Lead Sponsor
- Diakonhjemmet Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care Conventional current follow-up strategy Patient-initiated care Patient-initiated care No pre-scheduled visits or remote monitoring. Remote monitoring Remote monitoring Remote monitoring by health professionals at the hospital
- Primary Outcome Measures
Name Time Method Low disease activity at follow-up 18 months The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 18-months follow-up
- Secondary Outcome Measures
Name Time Method Ankylosing Spondylitis Disease Activity Score (ASDAS) Every month, maximum 18 months Monthly for a subgroup among the Remote monitoring group. ASDAS is a clinical measure of disease activity calculated from four PROs and CRP (or ESR if CRP is not available). The formula for calculating ASDAS CRP = 0.12 × back pain + 0.06 × duration of morning stiffness + 0.11 × patient global + 0.07 × peripheral pain/swelling + 0.58×Ln(CRP + 1)). Higher values indicate worse outcome.
Patient global assessment of disease activity 3, 6, 9, 12, 15 and 18 months Reported every third month by the Patient-initiated care group: Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome
Patient-reported flare 3, 6, 9, 12, 15 and 18 months Reported every third month by the Patient-initiated care group. Patient-reported experience of a significant worsening of symptoms (reflecting a flare in disease activity), response options: no, yes, uncertain. If yes or uncertain, they will be asked which date the flare occurred and the number of days it lasted.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Every month, maximum 18 months Reported monthly by the a subgroup among the Remote monitoring group. Patient-reported disease activity last 7 days on 6 items using a NRS 0-10. The score is the sum (of the first four individual questions and the mean of questions five and six) divided by five. The sum score range 0-10; higher value indicate worse outcome.
Bath Ankylosing Spondylitis Functional Index (BASFI) Baseline, 6, 12 and 18 months 10 item questionnaire (NRS 0-10) used to assess disease activity last 7 days. The score is the sum of each individual question divided by 10, higher value indicate worse outcome.
Patient-reported global change in activity impairment 6, 12 and 18 months Single item with seven-point response scale ranging from "Much worse" to "Much better".
Daily steps Through study completion, maximum 18 months Remote monitoring and Patient-initiated care groups, number of steps during daytime captured by wearing a smartwatch
Adverse events Through study completion, maximum 18 months Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Patient-reported global change in disease activity 6, 12 and 18 months Single item with seven-point response scale ranging from "Much worse" to "Much better".
Tender joint count Baseline, through study completion, and 18 months At extra visits/withdrawals/early discontinuation in the Remote monitoring and Patient-initiated care groups, For the Control group, examiner assessed MCP1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet
Costs related to hospital visits Baseline Self-reported travel distance in kilometres to the hospital.
The need to take time off work for hospital visits or video consultations Baseline If in paid work, the need to take time off from work is indicated as yes or no.
C-Reactive Protein (CRP) Every month, maximum 18 months CRP measured at home in a subgroup among the Remote monitoring group
Activity Impairment Baseline, 6, 12 and 18 months Item no.6 from Work Productivity and Activity Impairment (WPAI): self-reported activity impairment on a NRS 0-10; higher value indicate worse outcome.
Pain (general) Baseline, 6, 12 and 18 months Self-reported pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Joint pain Baseline, 6, 12 and 18 months Self-reported joint pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Sleep impairment Baseline, 6, 12 and 18 months 1 item from Pittsburgh Sleep Quality Index, self-reported sleep impairment in last month due to pain with 4 response categories ranging "Not during the past month" to "Three or more times a week" ; higher value indicate worse outcome.
Patient satisfaction with care Baseline, 6, 12 and 18 months 1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome
Swollen joint count Baseline, through study completion, and 18 months At extra visits/withdrawals/early discontinuation in the Remote monitoring and Patient-initiated care groups, For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet
Mean pulse level Through study completion, maximum 18 months Remote monitoring and Patient-initiated care groups, mean pulse level during daytime captured by wearing a smartwatch
Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L) Baseline, 6, 12 and 18 months 6 item utility instrument for measurement of health related quality of life, 5 first items with 5 response categories, item no.6: self-reported health status on a 0-100 mm scale
Concomitant medication Baseline, 6, 12 and 18 months Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register
Heel enthesitis Baseline, through study completion, and 18 months At extra visits/withdrawals/early discontinuation in the Remote monitoring and Patient-initiated care groups, , the presence of heel enthesitis is examined clinically by a health professional. Scored as not present/present right heel/present left heel/present both heels.
Health care utilization Baseline, 6, 12 and 18 months Self-reported health care use and national register data on consultations and treatment in secondary and primary health care
Extra visits, telephone and video consultations Through study completion, maximum 18 months Number of extra visits to the hospital or video consultations with a health care provider
eHealth literacy Baseline 20 items from 4 domains of the eHealth Literacy Questionnaire (eHLQ). Four point response scale, sum domain score range 1-4. Lower scores indicate lower eHealth literacy.
Body signs and symptoms 18 months To what degree do you understand your body's signs and symptoms. Single item, 4-point Likert scale (not at all - to a large degree + do not know-option)
Withdrawals/Early discontinuation Through study completion, maximum 18 months Number of withdrawals/early discontinuation
Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale Baseline Self-efficacy/confidence in using smartphone, tablet, computer, app's, secure login and digital health services. 6 items with Likert scale response categories: Never used, Very bad, Bad, Neither good nor bad, Good, Very good. Score range 1-5; higher scores indicate higher self-efficacy.
Patient satisfaction with remote monitoring or patient-initiated care 18 months Service User Technology Acceptability Questionnaire (SUTAQ) reported by the Patient-initiated care group. 3 of 22 items: #1, #10 and #11. Score range 1-6. Higher scores in indicate higher acceptability with telehealth.
Preferred follow-up strategy 18 months One item on whether the preferred follow-up strategy would be Remote monitoring or Patient-initated care reported by the two intervention groups only.
Trial Locations
- Locations (1)
Diakonhjemmet Hospital
🇳🇴Oslo, Norway