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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
243
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.
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 .
Diakonhjemmet Hospital
Oslo, Norway
Low disease activity at follow-up
The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 6-months follow-up
Time frame: 6 months
Low disease activity at follow-up
The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 12- months follow-up
Time frame: 12 months
Low disease activity at follow-up
The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 18-months follow-up
Time frame: 18 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Ankylosing Spondylitis Disease Activity Score (ASDAS) is a clinical measure of disease activity calculated from four patient-reported outcomes (PROs) and C-reactive Protein (CRP) (or erythrocyte sedimentation rate (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.
Time frame: Baseline, 6, 12 and 18 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
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.
Time frame: Every month, maximum 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Patient-reported disease activity last 7 days on 6 items using a numeric rating scale (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.
Time frame: Baseline, 6, 12 and 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Monthly reported by the Remote monitoring group if disease worsening. 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.
Time frame: Every month, maximum 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Reported every third month by the Patient-initiated care group if disease worsening. 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.
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Time frame: Every month, maximum 18 months
C-Reactive Protein (CRP)
CRP measured at home in a subgroup among the Remote monitoring group
Time frame: Every month, maximum 18 months
Patient global assessment of disease activity
Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome
Time frame: Baseline, 6, 12 and 18 months
Patient global assessment of disease activity
Monthly reported by the Remote monitoring group. Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome
Time frame: Every month, maximum 18 months
Patient global assessment of disease activity
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
Time frame: 3, 6, 9, 12, 15 and 18 months
Patient-reported flare
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.
Time frame: 6, 12 and 18 months
Patient-reported flare
Monthly reported by the Remote monitoring 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.
Time frame: Every month, maximum 18 months
Patient-reported flare
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.
Time frame: 3, 6, 9, 12, 15 and 18 months
Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Time frame: Baseline, 6, 12 and 18 months
Activity Impairment
Item no.6 from Work Productivity and Activity Impairment (WPAI): self-reported activity impairment on a NRS 0-10; higher value indicate worse outcome.
Time frame: Baseline, 6, 12 and 18 months
Patient-reported global change in disease activity
Single item with seven-point response scale ranging from "Much worse" to "Much better".
Time frame: 6, 12 and 18 months
Patient-reported global change in activity impairment
Single item with seven-point response scale ranging from "Much worse" to "Much better".
Time frame: 6, 12 and 18 months
Pain (general)
Self-reported pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Time frame: Baseline, 6, 12 and 18 months
Joint pain
Self-reported joint pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Time frame: Baseline, 6, 12 and 18 months
Sleep impairment
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.
Time frame: Baseline, 6, 12 and 18 months
Patient satisfaction with care
1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome
Time frame: Baseline, 6, 12 and 18 months
Daily steps
Remote monitoring and Patient-initiated care groups, number of steps during daytime captured by wearing a smartwatch
Time frame: Through study completion, maximum 18 months
Mean pulse level
Remote monitoring and Patient-initiated care groups, mean pulse level during daytime captured by wearing a smartwatch
Time frame: Through study completion, maximum 18 months
Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)
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
Time frame: Baseline, 6, 12 and 18 months
Concomitant medication
Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register
Time frame: Baseline, 6, 12 and 18 months
Swollen joint count
For the Control group, examiner assessed metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5, wrists, elbows, shoulders, ankles, forefeet
Time frame: Baseline, 6, 12 and 18 months
Swollen joint count
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
Time frame: Baseline, through study completion, and 18 months
Tender joint count
For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet
Time frame: Baseline, 6, 12 and 18 months
Tender joint count
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
Time frame: Baseline, through study completion, and 18 months
Heel enthesitis
For the Control group, 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.
Time frame: Baseline, 6, 12 and 18 months
Heel enthesitis
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.
Time frame: Baseline, through study completion, and 18 months
Costs related to hospital visits
Self-reported way of transport to the hospital; walking or bicycling/private car/public transportation/taxi/airplane/other.
Time frame: Baseline
Costs related to hospital visits
Self-reported travel distance in kilometres to the hospital.
Time frame: Baseline
The need to take time off work for hospital visits or video consultations
If in paid work, the need to take time off from work is indicated as yes or no.
Time frame: Baseline
Health care utilization
Self-reported health care use and national register data on consultations and treatment in secondary and primary health care
Time frame: Baseline, 6, 12 and 18 months
Extra visits, telephone and video consultations
Number of extra visits to the hospital or video consultations with a health care provider
Time frame: Through study completion, maximum 18 months
Withdrawals/Early discontinuation
Number of withdrawals/early discontinuation
Time frame: Through study completion, maximum 18 months
Adverse events
Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Time frame: Through study completion, maximum 18 months
Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale
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.
Time frame: Baseline
eHealth literacy
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.
Time frame: Baseline
Body signs and symptoms
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)
Time frame: 18 months
Patient satisfaction with remote monitoring or patient-initiated care
Service User Technology Acceptability Questionnaire (SUTAQ) reported by the Remote monitoring group. 22 items in 5 subscales. Score range 1-6. Higher scores in subscales 1,2 and 5/lower scores in subscales 3 and 4 indicate higher acceptability with telehealth.
Time frame: 18 months
Patient satisfaction with remote monitoring or patient-initiated care
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.
Time frame: 18 months
Preferred follow-up strategy
One item on whether the preferred follow-up strategy would be Remote monitoring or Patient-initated care reported by the two intervention groups only.
Time frame: 18 months