NCT05725577

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

December 13, 2022

Last Update Submit

November 21, 2024

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Number of rheumatology teleconsultations (email, telephone, video)

    12 month period

  • DAS28

    12 month period

  • PROMs: disease activity score (RAPID3)

    12 month period

  • PROMs: Patient acceptable symptom state (PASS)

    12 month period

  • PROMs: participation (WPAI)

    12 month period

  • +10 more secondary outcomes

Study Arms (2)

Care via the telemedicine system

OTHER

Intervention

Other: care via the telemedicine system

Standard care

OTHER

Control

Other: Routine care

Interventions

care via the telemedicine systemOTHER

Care via the telemedicine system

Care via the telemedicine system
Routine careOTHER

Routine care

Standard care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all consecutive patients;
  • signed, written informed consent;
  • 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.

You may not qualify if:

  • severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Harald Vonkeman, MD

    University of Twente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 13, 2022

First Posted

February 13, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL
Time Frame
After publication
Access Criteria
Upon reasonable request to p.m.tenklooster@utwente.nl

Locations

NL(1)