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| Name | Class |
|---|---|
| University of Twente | OTHER |
| Reade Rheumatology Research Institute | OTHER |
| Maastricht University Medical Center | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care via the telemedicine system | Other | Intervention |
|
| Standard care | Other | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| care via the telemedicine system | Other | Care via the telemedicine system |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Vonkeman, MD | University of Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Overijssel | 7512KZ | Netherlands |
All collected IPD
After publication
Upon reasonable request to p.m.tenklooster@utwente.nl
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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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| Routine care | Other | Routine care |
|
| 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |