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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Norway1 site
  • Diakonhjemmet Hospital

    Oslo, 0319

Other trials in Norway

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:

  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.

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 groups in NCT05031767
Study groupRoleWhat they receive
Usual careActive comparatorConventional current follow-up strategy
Receives: Other: Usual care
Remote monitoringExperimentalRemote monitoring by health professionals at the hospital
Receives: Other: Remote monitoring
Patient-initiated careExperimentalNo 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. C-Reactive Protein (CRP)

    CRP measured at home in a subgroup among the Remote monitoring group

    Measured: Every month, maximum 18 months

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. Costs related to hospital visits

    Self-reported travel distance in kilometres to the hospital.

    Measured: Baseline

  34. 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

  35. 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

  36. 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

  37. Withdrawals/Early discontinuation

    Number of withdrawals/early discontinuation

    Measured: Through study completion, maximum 18 months

  38. Adverse events

    Number of adverse events, serious adverse events, and withdrawals because of adverse events.

    Measured: Through study completion, maximum 18 months

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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.

  1. First posted2 Sep 2021
  2. Study start7 Sep 2021
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2024

Resources

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)
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

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.

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