Rheum@Home: RA Remote Patient Monitoring (R@H)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: care via the telemedicine system; Other: Routine care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512KZ
      • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of rheumatology outpatient visits with rheumatologists and nurses	Number of rheumatology outpatient visits with rheumatologists and nurses	12 month period
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medisch Spectrum Twente
• Collaborators: Maastricht University Medical Center; Reade Rheumatology Research Institute; University of Twente
• Investigators: Principal Investigator: Harald Vonkeman, MD, University of Twente

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: R@H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Upon reasonable request to p.m.tenklooster@utwente.nl
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No