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

NCT ID: NCT03428763

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2020-08-18

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).

Detailed Description

The aim of RA therapy is to reduce disease activity, joint destruction, symptoms, and disability. The prevailing therapeutic approach is an aggressive pharmacological disease control, with readily available conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in first line. The csDMARDs goes a long way towards reductions in disease activity, symptoms, and disability. However, if satisfactory disease control is not achieved by csDMARDS, addition of biologic medicines can be necessary.

With the efficacy of all these pharmacological options and the current view on "Treat-to-Target" (T2T), RA patients should have excellent prospects. However, despite the evidence to support a T2T strategy it is anticipated that many patients across various countries in Europe have active disease and suffer from increasing disability; this might be a consequence of bad access to optimal care, as well as possibly a lack of reimbursement of biological agents. Currently, the proposed T2T strategies are managed in the clinic by physicians, nurses and biometricians, which is expensive and time consuming for both patients and health care professionals (HCPs).

Telemonitoring and eHealth solutions for assessing patients with chronic illnesses as diabetes, asthma and hypertension have previously shown great advantages in better disease control and improvement of symptoms. A similar eHealth solution for patients with RA is expected to be advantageous both for patients and the health care system.

The current trial is designed to assess if an eHealth solution for homebased disease activity monitoring is superior to the standard clinical disease monitoring strategy with respect to T2T goals. The main research question is 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.

Conditions

Arthritis, Rheumatoid; Telerehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Homebased disease monitoring (eHealth)

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

Group Type: EXPERIMENTAL

Homebased disease monitoring (eHealth)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Standard clinical disease monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frederiksberg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henning Bliddal

Head of the Parker Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henning Bliddal, DMSc

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute

Locations

Institute of Rheumatology, Charles University

Prague, Prague, Czechia

The Parker Institute, Frederiksberg Hospital

Copenhagen, , Denmark

Countries

Czechia; Denmark

Other Identifiers

APPI-100.02

Identifier Type: -

Identifier Source: org_study_id