Clinical trial NCT05725577: Rheum@Home: RA Remote Patient Monitoring
Official title: Rheum@Home: Rheumatoid Arthritis Care in the 21th Century
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Reade Rheumatology Research Institute
name: Maastricht University Medical Center
First posted: 2023-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

* 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of rheumatology outpatient visits with rheumatologists and nurses
timeFrame: 12 month period
measure: Patient-reported quality of care
timeFrame: 12 month period
Secondary outcomes:
measure: Number of rheumatology teleconsultations (email, telephone, video)
timeFrame: 12 month period
measure: DAS28
timeFrame: 12 month period
measure: PROMs: disease activity score (RAPID3)
timeFrame: 12 month period
measure: PROMs: Patient acceptable symptom state (PASS)
timeFrame: 12 month period
measure: PROMs: participation (WPAI)
timeFrame: 12 month period
measure: PROMs: pain (NRS)
timeFrame: 12 month period
measure: PROMs: fatigue (NRS)
timeFrame: 12 month period
measure: PROMs: physical function (HAQ-DI)
timeFrame: 12 month period
measure: PROMs: health related quality of life (EQ5D)
timeFrame: 12 month period
measure: PROMs: health related quality of life (SF36)
timeFrame: 12 month period
measure: Physical performance: 50 meter walking test
timeFrame: 12 month period
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 12 month period
measure: Cost-effectiveness: healthcare utilization questionnaire
timeFrame: 12 month period
measure: Patient experience: System usability scale (SUS)
timeFrame: 12 month period
measure: Patient experience: Perceived efficacy in patient-physician interactions (PEPPI-5)
timeFrame: 12 month period
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
affiliation: University of Twente
name: Harald Vonkeman, MD
role: PRINCIPAL_INVESTIGATOR
References: