R@H: Rheum@Home: RA Remote Patient Monitoring
Study Details
Study Description
Brief Summary
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
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complete questionaires every 4 weeks
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perform a walking test every 4 weeks
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routine lab
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Care via the telemedicine system Intervention |
Other: care via the telemedicine system
Care via the telemedicine system
|
| Other: Standard care Control |
Other: Routine care
Routine care
|
Outcome Measures
Primary Outcome Measures
- Number of rheumatology outpatient visits with rheumatologists and nurses [12 month period]
Number of rheumatology outpatient visits with rheumatologists and nurses
- Patient-reported quality of care [12 month period]
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
Secondary Outcome Measures
- Number of rheumatology teleconsultations (email, telephone, video) [12 month period]
Number of rheumatology teleconsultations (email, telephone, video)
- DAS28 [12 month period]
Disease Activity Score
- PROMs: disease activity score (RAPID3) [12 month period]
PROMs: disease activity score (RAPID3)
- PROMs: Patient acceptable symptom state (PASS) [12 month period]
PROMs: Patient acceptable symptom state (PASS)
- PROMs: participation (WPAI) [12 month period]
PROMs: participation (WPAI)
- PROMs: pain (NRS) [12 month period]
PROMs: pain (NRS)
- PROMs: fatigue (NRS) [12 month period]
PROMs: fatigue (NRS)
- PROMs: physical function (HAQ-DI) [12 month period]
PROMs: physical function (HAQ-DI)
- PROMs: health related quality of life (EQ5D) [12 month period]
PROMs: health related quality of life (EQ5D)
- PROMs: health related quality of life (SF36) [12 month period]
PROMs: health related quality of life (SF36)
- Physical performance: 50 meter walking test [12 month period]
Physical performance: 50 meter walking test
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [12 month period]
(S)AE's assessed by CTCAE v4.0
- Cost-effectiveness: healthcare utilization questionnaire [12 month period]
Cost-effectiveness: healthcare utilization questionnaire
- Patient experience: System usability scale (SUS) [12 month period]
Patient experience: System usability scale (SUS)
- Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5) [12 month period]
Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
Eligibility Criteria
Criteria
Inclusion Criteria:
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all consecutive patients;
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signed, written informed consent;
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18 -75 years of age;
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clinical diagnosis of RA;
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≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
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able to read and understand simple Dutch language instructions;
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ownership or access to a smartphone, tablet or computer and having internet access;
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medisch Spectrum Twente | Enschede | Overijssel | Netherlands | 7512KZ |
Sponsors and Collaborators
- Medisch Spectrum Twente
- University of Twente
- Reade Rheumatology Research Institute
- Maastricht University Medical Center
Investigators
- Principal Investigator: Harald Vonkeman, MD, University of Twente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R@H