Rheum@Home: RA Remote Patient Monitoring

Not Applicable

Withdrawn

• Conditions: Rheumatoid Arthritis
• Interventions: Other: care via the telemedicine system; Other: Routine care

• Registration Number: NCT05725577
• Lead Sponsor: Medisch Spectrum Twente

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Study Start: 2023-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care via the telemedicine system	care via the telemedicine system	Intervention
Standard care	Routine care	Control

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cost-effectiveness: healthcare utilization questionnaire	12 month period	Cost-effectiveness: healthcare utilization questionnaire
PROMs: participation (WPAI)	12 month period	PROMs: participation (WPAI)
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: 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
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)

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands