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

NCT03428763 | Withdrawn

• 1 other identifier: APPI-100.02
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Arthritis, Rheumatoid; Telerehabilitation; controlled randomised trial

Outcome Measures

Primary Outcomes (1)

• Average DAS28-CRP over time

  The Disease Activity Score (DAS) is a combined index that has been developed to measure the disease activity in patients with RA. It is a composite of standard clinical, laboratory data, and patient-reported data. The DAS28-CRP requires a standard blood sample (20 ml) to be drawn and analysed.

  6 months from baseline

Secondary Outcomes (16)

• DAS28-CRP<3.2

  6 months from baseline

• DAS28-CRP<2.6

  6 months from baseline

• Remission

  6 months from baseline

• The Short Form (36) Health Survey(The SF-36)

  Change in the overall scores of the short form 36 questionnaire

• Swollen-joint count,

  6 months from baseline

Study Arms (2)

Homebased disease monitoring (eHealth)

EXPERIMENTAL

Participants allocated to the intervention group will be trained in self-monitoring of their RA

Device: Homebased disease monitoring (eHealth)

Standard clinical disease monitoring

ACTIVE COMPARATOR

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.

Other: Standard clinical disease monitoring

Interventions

Homebased disease monitoring (eHealth) DEVICE

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.

Homebased disease monitoring (eHealth)

Standard clinical disease monitoring OTHER

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.

Standard clinical disease monitoring

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with rheumatoid arthritis
• Diagnosed with RA \> 12 months
• Age between 18 and 85 years
• Computer and Internet connection at home and ability to employ these
• Hand function that allows self-testing of blood test at home.

You may not qualify if:

• Blood samples (creatinine, haemoglobin) outside lower normal limit - 5 % and upper normal limit + 5 % at screening.
• Blood samples (thrombocytes and leukocytes) outside lower normal limit - 15 % and upper normal limit + 15 % at screening
• Blood samples (ALT) outside lower normal limit - 100 % and upper normal limit + 100 % at screening
• Previously diagnosed with neutropenia and/or pancytopenia
• Dementia or other cognitive/physical deficiency that prevents participation
• Vision impairment that prevents the use of the devices and computer.

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (2)

Institute of Rheumatology, Charles University

Prague, Prague, 128 50, Czechia

Location

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Henning Bliddal, DMSc

  The Parker Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Parker Institute

Model Details: The current trial is designed to assess 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 RA.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: August 18, 2020
• Primary Completion: August 18, 2020
• Study Completion: August 18, 2020
• Last Updated: February 27, 2025

Record last verified: 2020-09

Locations

DK (1); CZ (1)