Remote Care in People With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Other: Conventional follow-upOther: Remote monitoring
- Registration Number
- NCT05496855
- Lead Sponsor
- Diakonhjemmet Hospital
- Brief 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional follow-up Conventional follow-up Conventional follow-up strategy with blood tests and face-to-face visits at the hospital every 6 months Remote monitoring Remote monitoring 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.
- Primary Outcome Measures
Name Time Method Proportion maintaining comprehensive disease control 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 Outcome Measures
Name Time Method Self-reported disease activity (intervention group) 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
Proportion in remission/low disease activity (DAS28) 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.
Change in joint damage progression 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.
Disease activity in conjunction with consultation (DAS28) 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 activityDisease activity in conjunction with consultation (CDAI) 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 activityPatient-reported disease flares (control group) 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.
Number of consultations/contacts at the hospital From baseline to 2 years Reported by research nurse or study doctor when in contact with a patient.
Activity impairment (intervention group) 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.
Proportion in remission/low disease activity (CDAI) 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.
Activity impairment (control group) 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.
The need to take time off for hospital visits or video consultation Baseline If in paid work, the need to take time off from work is indicated as yes or no.
C-Reactive Protein (CRP) (intervention group) Monthly until 2 years Blood test measured at home in a subgroup among the intervention group
Health care utilization 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.
Costs related to hospital visits 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
Self-reported disease activity (control group) 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
Health-related quality of life 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
Patient-reported disease flares (intervention group) 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.
Pain (control group) 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)
Joint pain (intervention group) 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)
Joint pain (control group) 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)
Medication use Baseline, 6 months, 12 months, 18 months, 2 years Medication, contomitant medication and any change in medication during the study period
Patient acceptable symptom state 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.
Adverse events Through study completion, maximum 2 years Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Patient satisfaction with care 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
C-Reactive Protein (CRP) (control group) Baseline, 6 months, 12 months, 18 months and 2 years Blood test at hospital or general practitioner
Modified Health Assessment Questionnaire (MHAQ) Baseline, 6 months, 12 months, 18 months, 2 years 8 question concerning physical function, scored from 0 (no problems) to 3 (impossible to perform)
PROMIS Physical function Baseline, 6 months, 12 months, 18 months, 2 years 4 questions concerning physical function measured on a 5 point Likert scale
Sleep impairment 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.
Withdrawals/early discontinuation Through study completion, maximum 2 years Number of withdrawals/early discontinuation
Patient satisfaction with remote monitoring 2 years Telehealth usability questionnaire (TUQ) 21 items scored from 1-7, higher score indicate higher satisfaction with telehealth
Pain (intervention group) Baseline and monthly until 2 years Self-reported pain measured on a 11-point NRS (0=no pain; 10=worst possible pain)
Swollen joint count 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
Tender joint count 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
Extra visits, telephone and video consultations Through study completion, maximum 2 years Number of extra visits to the hospital or video consultations with a healthcare provider
Physical activity Baseline, 6 months, 12 months, 18 months, 2 years 3 questions assessing frequency, intensity and duration of physical activity last week
Fatigue 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)
eHealth literacy Baseline eHEALS questionnaire, 9 items measured on a 5 point Likert scale, with higher score indicating better health literacy
Patient-reported self-efficacy for using different digital devices, secure login and digital health services 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.
Trial Locations
- Locations (1)
Diakonhjemmet Hospital
🇳🇴Oslo, Norway