Rheum@Home: RA Remote Patient Monitoring

Rheumatoid Arthritis Clinical Trial

— R@H  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05725577
• Other study ID #: R@H
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2023
• Source: Medisch Spectrum Twente
• Contact: Mirjam Hegeman
• Phone: +31534872450
• Email: M.Hegeman[@]MST.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 - 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• care via the telemedicine system
Care via the telemedicine system
• Routine care
Routine care

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel

Sponsors (4)

Lead Sponsor	Collaborator
Medisch Spectrum Twente	Maastricht University Medical Center, Reade Rheumatology Research Institute, University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

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