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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05725577
Other study ID # R@H
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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