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Active, Not Recruiting

NCT Number: NCT05496855

Remote Care in People With Rheumatoid Arthritis

This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up compared to the conventional follow-up regimen with regular hospital visits.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet Hospital

Oslo, 0319, Norway

About this study

The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups:

  • Control group: conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month.
  • Remote monitoring: monthly remote monitoring of PROs and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits.

Participants will be followed for 24 months. Primary outcome is proportionn maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up1.

  • Structural: Assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space narrowing (0-168)), with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score <1 unit/year (<2 units from inclusion to 2-year follow-up).
  • Functional: Measured by Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important3. Maintenance of functional treatment target is defined as a worsening <0.25 from inclusion to 2-year follow-up.
  • Clinical: Measured by DAS28, categorized into remission (<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category.

We will use a 15% non-inferiority margin.

The study will comprise an internal pilot study the first 6 months for all participants in the intervention group.

The study will also include qualitative research including semi-structured interviews and observations of patients in the intervention group and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant, non-nursing female ≥18 years of age at screening
  • Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)
  • Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months
  • Low disease activity or remission (CDAI<10 / DAS28<3.2) at inclusion
  • <2 swollen joints
  • Not deemed inappropriate for remote monitoring by the healthcare provider
  • Capable of understanding and signing an informed consent form
  • Access to a smartphone or tablet
  • Able to speak and understand Norwegian language

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)
  • Treated with intravenous DMARD (e.g., rituximab and infliximab)

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 Aspartate Transaminate (AST)/Alanine Transaminase (ALT) >3 x 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.
  • Deemed unsuitable for remote monitoring by medical doctor

Treatment and study plan

Conventional follow-up

Other

Patients in the conventional/usual care arm will be treated according to current conventional follow-up regimen with PROs, blood tests, and face-to-face visits with an experienced nurse or a rheumatologist every 6 months. They can contact the hospital if they are experience worsening of their disease.

Other names: Control group

Remote monitoring

Other

The patients in the remote monitoring arm will use a web-app (Youwell) for self-reporting patient reported outcomes (PROs) and CRP/ESR, displaying results for PROs over time, and for synchronous (video) or asynchronous (chat) communication with healthcare providers. The patients will receive a SMS reminder for "tasks" (e.g., self-reporting PROs or registering results from blood tests) every month.

A study coordinator/nurse will monitor the PROs and blood test (CRP/ESR) results, and respond to chat messages. Based on the algorithm, a triaging functionality in the Youwell platform will aid healthcare providers in highlighting which patients needs attention.

Other names: Intervention group

Primary outcomes

  1. Proportion maintaining comprehensive disease control

    Time frame: Baseline and 2 years

    Comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up.

    • Structural: Radiographs of hands and feet according to the van der Heijde modified Sharpe score, with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score <1 unit/year (<2 units from inclusion to 2-year follow-up).
    • Functional: Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important. Maintenance of functional treatment target is defined as a worsening <0.25 from inclusion to 2-year follow-up.
    • Clinical: DAS28, categorized into remission (<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category.

Secondary outcomes

  1. Change in joint damage progression

    Time frame: Baseline and 2 years

    Joint damage progression from inclusion to 2-year follow-up assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space narrowing (0-168)), with a total range of 0-448. Measured as a continuous variable.

  2. Self-reported disease activity (intervention group)

    Time frame: Monthly until 2 years

    Measured with patient global assessment of disease activity (0-10 scale, 0=no disease activity), estimated as change across all timepoints

  3. Self-reported disease activity (control group)

    Time frame: Baseline, 6 months, 12 months, 18 months and 2 years

    Measured with patient global assessment of disease activity (0-10 scale, 0=no disease activity), estimated as change across all timepoints

  4. Health-related quality of life

    Time frame: Baseline, 6 months, 12 months, 18 months and 2 years

    Measured with EQ5D-5L, 5 questions used to calculate an utility score (0-1, 1= best health), assessed as a total score across all timepoints

  5. Proportion in remission/low disease activity (CDAI)

    Time frame: Baseline and 2 years

    Measured with CDAI (patient global assessment of disease activity, number of tender and swollen joints, physician assessment of disease activity). Remission/low disease activity defined as CDAI <10.

  6. Proportion in remission/low disease activity (DAS28)

    Time frame: Baseline and 2 years

    Measured with DAS28 (patient global assessment of disease activity, CRP/ESR, number of tender and swollen joints). Remission/low disease activity defined as DAS28 <3.2.

  7. Disease activity in conjunction with consultation (DAS28)

    Time frame: Any consultation from baseline to 2 years

    Measured with DAS28 (patient global assessment of disease activity, CRP/ESR, number of tender and swollen joints).

    DAS28 score: <2.6= remission; 2.6-<3.2=low disease activity; 3.2 -5.1= moderate disease activity; >5.2= high disease activity

  8. Disease activity in conjunction with consultation (CDAI)

    Time frame: Any consultation from baseline to 2 years

    Measured with CDAI (patient global assessment of disease activity, number of tender and swollen joints, physician assessment of disease activity).

    CDAI score: <=2.8 = remission; >2.8 - <=10 = low disease activity; >10 - <=22 = moderate disease activity; >22 = high disease activity

  9. Health care utilization

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    Costs related to self-reported healthcare use in primary and secondary health care. Patients will be asked if they have been seeking healthcare (yes/no), if yes, they will be asked to specify type of healthcare use and time used. This information will also be collected from national register data.

  10. Patient-reported disease flares (intervention group)

    Time frame: Every month until 2 years

    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.

  11. Patient-reported disease flares (control group)

    Time frame: 6 months, 12 months, 18 months, 2 years

    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.

  12. Adverse events

    Time frame: Through study completion, maximum 2 years

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

  13. Number of consultations/contacts at the hospital

    Time frame: From baseline to 2 years

    Reported by research nurse or study doctor when in contact with a patient.

  14. Activity impairment (intervention group)

    Time frame: Baseline and monthly until 2 years

    Item no.6 from Work Productivity and Activity Impairment (WPAI): self-reported activity impairment on a NRS 0-10; higher value indicate worse outcome.

  15. Activity impairment (control group)

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    Item no.6 from Work Productivity and Activity Impairment (WPAI): self-reported activity impairment on a NRS 0-10; higher value indicate worse outcome.

  16. Costs related to hospital visits

    Time frame: Baseline

    Self-reported travel distance (km and time) and way of transport (walking, bicycle, privat car, public transportation, taxi, airplane, other) in conjunction with consultation at the hospital

  17. The need to take time off for hospital visits or video consultation

    Time frame: Baseline

    If in paid work, the need to take time off from work is indicated as yes or no.

  18. C-Reactive Protein (CRP) (intervention group)

    Time frame: Baseline, 3, 6, 9, 12, 15, 18, 21 months and 2 years

    Blood test at hospital or general practitioner

  19. C-Reactive Protein (CRP) (control group)

    Time frame: Baseline, 6 months, 12 months, 18 months and 2 years

    Blood test at hospital or general practitioner

  20. C-Reactive Protein (CRP) (intervention group)

    Time frame: Monthly until 2 years

    Blood test measured at home in a subgroup among the intervention group

  21. Modified Health Assessment Questionnaire (MHAQ)

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    8 question concerning physical function, scored from 0 (no problems) to 3 (impossible to perform)

  22. PROMIS Physical function

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    4 questions concerning physical function measured on a 5 point Likert scale

  23. Pain (intervention group)

    Time frame: Baseline and monthly until 2 years

    Self-reported pain measured on a 11-point NRS (0=no pain; 10=worst possible pain)

  24. Pain (control group)

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    Self-reported pain measured on a 11-point NRS (0=no pain; 10=worst possible pain)

  25. Joint pain (intervention group)

    Time frame: Baseline and monthly until 2 years

    Self-reported joint pain measured on a 11-point NRS (0=no joint pain; 10=worst possible joint pain)

  26. Joint pain (control group)

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    Self-reported joint pain measured on a 11-point NRS (0=no joint pain; 10=worst possible joint pain)

  27. Sleep impairment

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    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.

  28. Medication use

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    Medication, contomitant medication and any change in medication during the study period

  29. Swollen joint count

    Time frame: Baseline, any hospital visits, 2 years

    Physician count of swollen joints; MCP 1-5, PIP 1-5, wrist, elbows, shoulders, ankles, MTP 1-5, at regular visits, extra visits, withdrawls, early discontinuation

  30. Tender joint count

    Time frame: Baseline, any hospital visits, 2 years

    Physician count of tender joints; MCP 1-5, PIP 1-5, wrist, elbows, shoulders, ankles, MTP 1-5, at regular visits, extra visits, withdrawls, early discontinuation

  31. Extra visits, telephone and video consultations

    Time frame: Through study completion, maximum 2 years

    Number of extra visits to the hospital or video consultations with a healthcare provider

  32. Withdrawals/early discontinuation

    Time frame: Through study completion, maximum 2 years

    Number of withdrawals/early discontinuation

  33. Physical activity

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    3 questions assessing frequency, intensity and duration of physical activity last week

  34. Fatigue

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue)

  35. Patient acceptable symptom state

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 years

    one question assessing the patient acceptable symptom state last week, 5 response options from very good to very bad.

  36. eHealth literacy

    Time frame: Baseline

    eHEALS questionnaire, 9 items measured on a 5 point Likert scale, with higher score indicating better health literacy

  37. Patient-reported self-efficacy for using different digital devices, secure login and digital health services

    Time frame: 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.

  38. Patient satisfaction with care

    Time frame: Baseline, 6 months, 12 months, 18 months, 2 year

    1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome

  39. Patient satisfaction with remote monitoring

    Time frame: 2 years

    Telehealth usability questionnaire (TUQ) 21 items scored from 1-7, higher score indicate higher satisfaction with telehealth

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases

Acronym: NOR-Flare

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Aug 11, 2022
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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