The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis. Participants will be asked to * complete questionaires every 4 weeks * perform a walking test every 4 weeks * routine lab * routine disease activity measurement by a qualified assessor Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Care via the telemedicine system
Routine care
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Number of rheumatology outpatient visits with rheumatologists and nurses
Number of rheumatology outpatient visits with rheumatologists and nurses
Time frame: 12 month period
Patient-reported quality of care
measured with visual analogue scale (VAS) scores (0-10; higher score indicates higher quality) in seven relevant domains: patients' satisfaction with health care, patients' experiences contacting their health-care providers, the extent to which health care meets patients' expectations, healthcare workers' timeliness of response to questions and symptoms, health-care workers' fulfilment of agreements, health-care workers attentiveness to acute situations, and hospital accessibility in case of symptoms. A mean score of 8 out of 10 or higher was predefined as perceived high quality
Time frame: 12 month period
Number of rheumatology teleconsultations (email, telephone, video)
Number of rheumatology teleconsultations (email, telephone, video)
Time frame: 12 month period
DAS28
Disease Activity Score
Time frame: 12 month period
PROMs: disease activity score (RAPID3)
PROMs: disease activity score (RAPID3)
Time frame: 12 month period
PROMs: Patient acceptable symptom state (PASS)
PROMs: Patient acceptable symptom state (PASS)
Time frame: 12 month period
PROMs: participation (WPAI)
PROMs: participation (WPAI)
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Time frame: 12 month period
PROMs: pain (NRS)
PROMs: pain (NRS)
Time frame: 12 month period
PROMs: fatigue (NRS)
PROMs: fatigue (NRS)
Time frame: 12 month period
PROMs: physical function (HAQ-DI)
PROMs: physical function (HAQ-DI)
Time frame: 12 month period
PROMs: health related quality of life (EQ5D)
PROMs: health related quality of life (EQ5D)
Time frame: 12 month period
PROMs: health related quality of life (SF36)
PROMs: health related quality of life (SF36)
Time frame: 12 month period
Physical performance: 50 meter walking test
Physical performance: 50 meter walking test
Time frame: 12 month period
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
(S)AE's assessed by CTCAE v4.0
Time frame: 12 month period
Cost-effectiveness: healthcare utilization questionnaire
Cost-effectiveness: healthcare utilization questionnaire
Time frame: 12 month period
Patient experience: System usability scale (SUS)
Patient experience: System usability scale (SUS)
Time frame: 12 month period
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Time frame: 12 month period