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ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis

NCT03428763 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-27

No results posted yet for this study

Summary

The aim of this study is to explore whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with rheumatoid arthritis (RA).

Conditions

  • Arthritis, Rheumatoid
  • Telerehabilitation

Interventions

DEVICE

Homebased disease monitoring (eHealth)

Participants allocated to the intervention group will be trained in self-monitoring (assessment of tender of swollen joints). Further they will be instructed in using a point-of-care CRP-measuring device to measure blood concentrations of C-reactive protein at their home, and to submit the self-monitoring results on a dedicated internet platform. These procedures represent a "virtual visit". The participants are instructed to have "virtual visit" (self-monitoring) every month from allocation. The scheduled "virtual visits" include * Joint score by the patient * Patient global disease activity measured on a 0-100 mm visual analogue scale. * CRP measurement on home-based device Based on the submitted data a DAS28-CRP is calculated and recorded in the eCRF.

OTHER

Standard clinical disease monitoring

Those allocated to the control arm of the study will continue usual clinical care (i.e. they will not self-monitor or have access to the eHealth solution). No other medication changes will be mandated and participating investigators will be asked to manage all other care according usual clinical practice. Individuals in the control group will not be given the option to self-monitor.

Sponsors & Collaborators

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Henning Bliddal, DMSc · The Parker Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2020-08-18
Completion
2020-08-18

Countries

  • Czechia
  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428763 on ClinicalTrials.gov