Axial SpondyloarthritisReMonitNCT05031767
Remote Monitoring of Axial Spondyloarthritis
A study testing Remote monitoring and Patient-initiated care in people with Axial Spondyloarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Remote monitoring and Patient-initiated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteNorway
- Study dates
- 7 Sep 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
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.
Read the detailed description
The trial will include Norwegian adult males and females with axial spondyloarthritis.
240 participants will be randomized 1:1:1 to either:
- 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
- Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform
- 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
- Being tested
- Usual care, Remote monitoring, Patient-initiated care
- Keywords
- rheumatic diseases, musculoskeletal diseases, joint diseases, arthritis
- Medical subject headings
- Axial Spondyloarthritis, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
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 monitoringOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Conventional current follow-up strategy Receives: Other: Usual care |
| Remote monitoring | Experimental | Remote monitoring by health professionals at the hospital Receives: Other: Remote monitoring |
| Patient-initiated care | Experimental | No pre-scheduled visits or remote monitoring. Receives: Other: Patient-initiated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 18 months
Secondary outcomes (44)
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.
Measured: 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.
Measured: Every month, maximum 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every month, maximum 18 months
C-Reactive Protein (CRP)
CRP measured at home in a subgroup among the Remote monitoring group
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6, 12 and 18 months
Concomitant medication
Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Costs related to hospital visits
Self-reported travel distance in kilometres to the hospital.
Measured: 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.
Measured: Baseline
Health care utilization
Self-reported health care use and national register data on consultations and treatment in secondary and primary health care
Measured: 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
Measured: Through study completion, maximum 18 months
Withdrawals/Early discontinuation
Number of withdrawals/early discontinuation
Measured: Through study completion, maximum 18 months
Adverse events
Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start7 Sep 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Osteras, Diakonhjemmet Hospital
- Investigators
- Tore Kvien, MD, Professor em, Study chair, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031767
- Sponsor's protocol ID
- REK no.:229187
- Acronym
- ReMonit
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38150310
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
- ClinicalTrials.gov ID
- NCT05031767
- Acronym / sponsor ID
- ReMonit / REK no.:229187
- Conditions
- Axial Spondyloarthritis
- Keywords
- rheumatic diseases, musculoskeletal diseases, joint diseases, arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careConventional current follow-up strategy |
| Remote monitoring | Experimental | Other: Remote monitoringRemote monitoring by health professionals at the hospital |
| Patient-initiated care | Experimental | Other: Patient-initiated careNo pre-scheduled visits or remote monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careConventional 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 | Usual care |
| Remote monitoringHospital 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 | Remote monitoring |
| Patient-initiated careNo 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. | Other | Patient-initiated care |
Primary outcome
Low disease activity at follow-up
Time frame: 6 months
The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 6-months follow-up
Low disease activity at follow-up
Time frame: 12 months
The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 12- months follow-up
Low disease activity at follow-up
Time frame: 18 months
The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 18-months follow-up
44 secondary outcomes
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Baseline, 6, 12 and 18 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Every month, maximum 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, 6, 12 and 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Every month, maximum 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, 3, 6, 9, 12, 15 and 18 months
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Every month, maximum 18 months
C-Reactive Protein (CRP)
Time frame: Every month, maximum 18 months
Patient global assessment of disease activity
Time frame: Baseline, 6, 12 and 18 months
Patient global assessment of disease activity
Time frame: Every month, maximum 18 months
Patient global assessment of disease activity
Time frame: 3, 6, 9, 12, 15 and 18 months
Patient-reported flare
Time frame: 6, 12 and 18 months
Patient-reported flare
Time frame: Every month, maximum 18 months
Patient-reported flare
Time frame: 3, 6, 9, 12, 15 and 18 months
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline, 6, 12 and 18 months
Activity Impairment
Time frame: Baseline, 6, 12 and 18 months
Patient-reported global change in disease activity
Time frame: 6, 12 and 18 months
Patient-reported global change in activity impairment
Time frame: 6, 12 and 18 months
Pain (general)
Time frame: Baseline, 6, 12 and 18 months
Joint pain
Time frame: Baseline, 6, 12 and 18 months
Sleep impairment
Time frame: Baseline, 6, 12 and 18 months
Patient satisfaction with care
Time frame: Baseline, 6, 12 and 18 months
Daily steps
Time frame: Through study completion, maximum 18 months
Mean pulse level
Time frame: Through study completion, maximum 18 months
Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)
Time frame: Baseline, 6, 12 and 18 months
Concomitant medication
Time frame: Baseline, 6, 12 and 18 months
Swollen joint count
Time frame: Baseline, 6, 12 and 18 months
Swollen joint count
Time frame: Baseline, through study completion, and 18 months
Tender joint count
Time frame: Baseline, 6, 12 and 18 months
Tender joint count
Time frame: Baseline, through study completion, and 18 months
Heel enthesitis
Time frame: Baseline, 6, 12 and 18 months
Heel enthesitis
Time frame: Baseline, through study completion, and 18 months
Costs related to hospital visits
Time frame: Baseline
Costs related to hospital visits
Time frame: Baseline
The need to take time off work for hospital visits or video consultations
Time frame: Baseline
Health care utilization
Time frame: Baseline, 6, 12 and 18 months
Extra visits, telephone and video consultations
Time frame: Through study completion, maximum 18 months
Withdrawals/Early discontinuation
Time frame: Through study completion, maximum 18 months
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
Time frame: Baseline
eHealth literacy
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 38150310Berg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore Kvien, MD, Professor em study chair
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote monitoring and Patient-initiated care in people with Axial Spondyloarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low disease activity at follow-up (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.