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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.
The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional follow-up | Active Comparator | Conventional follow-up strategy with blood tests and face-to-face visits at the hospital every 6 months |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion maintaining comprehensive disease control | Comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up.
| Baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Medical conditions:
Diagnostic assessments:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Therese Tveter, PhD | Diakonhjemmet Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakonhjemmet Hospital | Oslo | 0319 | Norway |
Data sharing of anonymous data may be possible upon reasonable request sent to the principal investigator.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Randomized controlled non-inferiority trial
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| 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. |
|
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| 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 6 months, 12 months, 18 months, 2 years |
| Adverse events | Number of adverse events, serious adverse events, and withdrawals because of adverse events. | 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. | 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. | 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. | 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 | 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. | Baseline |
| C-Reactive Protein (CRP) (intervention group) | Blood test at hospital or general practitioner | 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 | 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 | Monthly until 2 years |
| Modified Health Assessment Questionnaire (MHAQ) | 8 question concerning physical function, scored from 0 (no problems) to 3 (impossible to perform) | Baseline, 6 months, 12 months, 18 months, 2 years |
| PROMIS Physical function | 4 questions concerning physical function measured on a 5 point Likert scale | 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) | 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) | 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) | 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) | 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. | Baseline, 6 months, 12 months, 18 months, 2 years |
| Medication use | Medication, contomitant medication and any change in medication during the study period | 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 | 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 | 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 | Through study completion, maximum 2 years |
| Withdrawals/early discontinuation | Number of withdrawals/early discontinuation | Through study completion, maximum 2 years |
| Physical activity | 3 questions assessing frequency, intensity and duration of physical activity last week | 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) | 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. | 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 | 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. | Baseline |
| Patient satisfaction with care | 1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome | 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 | 2 years |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008722 | Methods |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |