Rheumatoid ArthritisNOR-FlareNCT05496855
Remote Care in People With Rheumatoid Arthritis
A study testing Conventional follow-up and Remote monitoring in people with Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Conventional follow-up and Remote monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteNorway
- Study dates
- 29 Sep 2022to 14 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
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- Capable of understanding and signing an informed consent form
- Access to a smartphone or tablet
- Able to speak and understand Norwegian language
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)
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases
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.
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Conventional follow-up, Remote monitoring
- Keywords
- remote care
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional follow-upOther
Also called Control group
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.
Remote monitoringOther
Also called Intervention group
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional follow-up | Active comparator | Conventional follow-up strategy with blood tests and face-to-face visits at the hospital every 6 months Receives: Other: Conventional follow-up |
| Remote monitoring | Experimental | Monthly remote monitoring of patient-reported outcomes and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits. Receives: Other: Remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion maintaining comprehensive disease control
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.
Measured: Baseline and 2 years
Secondary outcomes (39)
Change in joint damage progression
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.
Measured: Baseline and 2 years
Self-reported disease activity (intervention group)
Measured with patient global assessment of disease activity (0-10 scale, 0=no disease activity), estimated as change across all timepoints
Measured: Monthly until 2 years
Self-reported disease activity (control group)
Measured with patient global assessment of disease activity (0-10 scale, 0=no disease activity), estimated as change across all timepoints
Measured: Baseline, 6 months, 12 months, 18 months and 2 years
Health-related quality of life
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
Measured: Baseline, 6 months, 12 months, 18 months and 2 years
Proportion in remission/low disease activity (CDAI)
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.
Measured: Baseline and 2 years
Proportion in remission/low disease activity (DAS28)
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.
Measured: Baseline and 2 years
Disease activity in conjunction with consultation (DAS28)
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
Measured: Any consultation from baseline to 2 years
Disease activity in conjunction with consultation (CDAI)
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
Measured: Any consultation from baseline to 2 years
Health care utilization
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.
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
Patient-reported disease flares (intervention 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 until 2 years
Patient-reported disease flares (control 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: 6 months, 12 months, 18 months, 2 years
Adverse events
Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Measured: Through study completion, maximum 2 years
Number of consultations/contacts at the hospital
Reported by research nurse or study doctor when in contact with a patient.
Measured: From baseline to 2 years
Activity impairment (intervention group)
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 and monthly until 2 years
Activity impairment (control group)
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 months, 12 months, 18 months, 2 years
Costs related to hospital visits
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
Measured: Baseline
The need to take time off for hospital visits or video consultation
If in paid work, the need to take time off from work is indicated as yes or no.
Measured: Baseline
C-Reactive Protein (CRP) (intervention group)
Blood test at hospital or general practitioner
Measured: Baseline, 3, 6, 9, 12, 15, 18, 21 months and 2 years
C-Reactive Protein (CRP) (control group)
Blood test at hospital or general practitioner
Measured: Baseline, 6 months, 12 months, 18 months and 2 years
C-Reactive Protein (CRP) (intervention group)
Blood test measured at home in a subgroup among the intervention group
Measured: Monthly until 2 years
Modified Health Assessment Questionnaire (MHAQ)
8 question concerning physical function, scored from 0 (no problems) to 3 (impossible to perform)
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
PROMIS Physical function
4 questions concerning physical function measured on a 5 point Likert scale
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
Pain (intervention group)
Self-reported pain measured on a 11-point NRS (0=no pain; 10=worst possible pain)
Measured: Baseline and monthly until 2 years
Pain (control group)
Self-reported pain measured on a 11-point NRS (0=no pain; 10=worst possible pain)
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
Joint pain (intervention group)
Self-reported joint pain measured on a 11-point NRS (0=no joint pain; 10=worst possible joint pain)
Measured: Baseline and monthly until 2 years
Joint pain (control group)
Self-reported joint pain measured on a 11-point NRS (0=no joint pain; 10=worst possible joint pain)
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
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 months, 12 months, 18 months, 2 years
Medication use
Medication, contomitant medication and any change in medication during the study period
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
Swollen joint count
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
Measured: Baseline, any hospital visits, 2 years
Tender joint count
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
Measured: Baseline, any hospital visits, 2 years
Extra visits, telephone and video consultations
Number of extra visits to the hospital or video consultations with a healthcare provider
Measured: Through study completion, maximum 2 years
Withdrawals/early discontinuation
Number of withdrawals/early discontinuation
Measured: Through study completion, maximum 2 years
Physical activity
3 questions assessing frequency, intensity and duration of physical activity last week
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
Fatigue
Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue)
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
Patient acceptable symptom state
one question assessing the patient acceptable symptom state last week, 5 response options from very good to very bad.
Measured: Baseline, 6 months, 12 months, 18 months, 2 years
eHealth literacy
eHEALS questionnaire, 9 items measured on a 5 point Likert scale, with higher score indicating better health literacy
Measured: Baseline
Patient-reported self-efficacy for using different digital devices, secure login and digital health services
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
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 months, 12 months, 18 months, 2 year
Patient satisfaction with remote monitoring
Telehealth usability questionnaire (TUQ) 21 items scored from 1-7, higher score indicate higher satisfaction with telehealth
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start29 Sep 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
- Investigators
- Anne Therese Tveter, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496855
- Sponsor's protocol ID
- REK 457358
- Acronym
- NOR-Flare
- Status last verified
- Apr 2025
- First submitted
- 4 Aug 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing of anonymous data may be possible upon reasonable request sent to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT05496855
- Acronym / sponsor ID
- NOR-Flare / REK 457358
- Conditions
- Rheumatoid Arthritis
- Keywords
- remote care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 14 Oct 2028 (estimated)
- First posted
- 11 Aug 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Conventional follow-up | Active comparator | Other: Conventional follow-upConventional follow-up strategy with blood tests and face-to-face visits at the hospital every 6 months |
| Remote monitoring | Experimental | Other: Remote monitoringMonthly remote monitoring of patient-reported outcomes and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 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)
- Treated with intravenous DMARD (e.g., rituximab and infliximab)
- 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
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 |
|---|---|---|
| Conventional follow-upAlso: Control groupPatients 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 | Conventional follow-up |
| Remote monitoringAlso: Intervention groupThe 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 | Remote monitoring |
Primary outcome
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.
39 secondary outcomes
Change in joint damage progression
Time frame: Baseline and 2 years
Self-reported disease activity (intervention group)
Time frame: Monthly until 2 years
Self-reported disease activity (control group)
Time frame: Baseline, 6 months, 12 months, 18 months and 2 years
Health-related quality of life
Time frame: Baseline, 6 months, 12 months, 18 months and 2 years
Proportion in remission/low disease activity (CDAI)
Time frame: Baseline and 2 years
Proportion in remission/low disease activity (DAS28)
Time frame: Baseline and 2 years
Disease activity in conjunction with consultation (DAS28)
Time frame: Any consultation from baseline to 2 years
Disease activity in conjunction with consultation (CDAI)
Time frame: Any consultation from baseline to 2 years
Health care utilization
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Patient-reported disease flares (intervention group)
Time frame: Every month until 2 years
Patient-reported disease flares (control group)
Time frame: 6 months, 12 months, 18 months, 2 years
Adverse events
Time frame: Through study completion, maximum 2 years
Number of consultations/contacts at the hospital
Time frame: From baseline to 2 years
Activity impairment (intervention group)
Time frame: Baseline and monthly until 2 years
Activity impairment (control group)
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Costs related to hospital visits
Time frame: Baseline
The need to take time off for hospital visits or video consultation
Time frame: Baseline
C-Reactive Protein (CRP) (intervention group)
Time frame: Baseline, 3, 6, 9, 12, 15, 18, 21 months and 2 years
C-Reactive Protein (CRP) (control group)
Time frame: Baseline, 6 months, 12 months, 18 months and 2 years
C-Reactive Protein (CRP) (intervention group)
Time frame: Monthly until 2 years
Modified Health Assessment Questionnaire (MHAQ)
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
PROMIS Physical function
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Pain (intervention group)
Time frame: Baseline and monthly until 2 years
Pain (control group)
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Joint pain (intervention group)
Time frame: Baseline and monthly until 2 years
Joint pain (control group)
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Sleep impairment
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Medication use
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Swollen joint count
Time frame: Baseline, any hospital visits, 2 years
Tender joint count
Time frame: Baseline, any hospital visits, 2 years
Extra visits, telephone and video consultations
Time frame: Through study completion, maximum 2 years
Withdrawals/early discontinuation
Time frame: Through study completion, maximum 2 years
Physical activity
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Fatigue
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
Patient acceptable symptom state
Time frame: Baseline, 6 months, 12 months, 18 months, 2 years
eHealth literacy
Time frame: Baseline
Patient-reported self-efficacy for using different digital devices, secure login and digital health services
Time frame: Baseline
Patient satisfaction with care
Time frame: Baseline, 6 months, 12 months, 18 months, 2 year
Patient satisfaction with remote monitoring
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No. Data sharing of anonymous data may be possible upon reasonable request sent to the principal investigator.
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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.
Anne Therese Tveter, PhD principal investigator
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 Conventional follow-up and Remote monitoring in people with Rheumatoid Arthritis, 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 9 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion maintaining comprehensive disease control (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2025.