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

Frederiksberg University Hospital

Status: Withdrawn

Conditions: Telerehabilitation; Arthritis, Rheumatoid

Treatments: Other: Standard clinical disease monitoring; Device: Homebased disease monitoring (eHealth)

Study type: Interventional

Funder types: Other

Identifiers

NCT03428763

APPI-100.02

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Homebased disease monitoring (eHealth)

Experimental group

Description:

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

Treatment:

Device: Homebased disease monitoring (eHealth)

Standard clinical disease monitoring

Active Comparator group

Description:

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.

Treatment:

Other: Standard clinical disease monitoring