Rheum@Home: RA Remote Patient Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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Rheum@Home: Rheumatoid Arthritis Care in the 21th Century

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: care via the telemedicine system
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all consecutive patients; signed, written informed consent; 18 -75 years of age; clinical diagnosis of RA; ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist; able to read and understand simple Dutch language instructions; ownership or access to a smartphone, tablet or computer and having internet access; able to conduct a teleconsultation on a smartphone, tablet or computer. Exclusion Criteria: severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Care via the telemedicine system<br>Intervention | Other: care via the telemedicine system<br>* Care via the telemedicine system<br>|
| Other: Standard care<br>Control | Other: Routine care<br>* Routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rheumatology outpatient visits with rheumatologists and nurses | Number of rheumatology outpatient visits with rheumatologists and nurses | 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 | 12 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rheumatology teleconsultations (email, telephone, video) | Number of rheumatology teleconsultations (email, telephone, video) | 12 month period | 
| DAS28 | Disease Activity Score | 12 month period | 
| PROMs: disease activity score (RAPID3) | PROMs: disease activity score (RAPID3) | 12 month period | 
| PROMs: Patient acceptable symptom state (PASS) | PROMs: Patient acceptable symptom state (PASS) | 12 month period | 
| PROMs: participation (WPAI) | PROMs: participation (WPAI) | 12 month period | 
| PROMs: pain (NRS) | PROMs: pain (NRS) | 12 month period | 
| PROMs: fatigue (NRS) | PROMs: fatigue (NRS) | 12 month period | 
| PROMs: physical function (HAQ-DI) | PROMs: physical function (HAQ-DI) | 12 month period | 
| PROMs: health related quality of life (EQ5D) | PROMs: health related quality of life (EQ5D) | 12 month period | 
| PROMs: health related quality of life (SF36) | PROMs: health related quality of life (SF36) | 12 month period | 
| Physical performance: 50 meter walking test | Physical performance: 50 meter walking test | 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 | 12 month period | 
| Cost-effectiveness: healthcare utilization questionnaire | Cost-effectiveness: healthcare utilization questionnaire | 12 month period | 
| Patient experience: System usability scale (SUS) | Patient experience: System usability scale (SUS) | 12 month period | 
| Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5) | Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5) | 12 month period |