Clinical trial NCT03428763: ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis
Official title: ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis: A 6 Months Multicentre, eHealth Randomised, Non-blinded, Parallel-group, Superiority Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arthritis, Rheumatoid
Telerehabilitation
Keywords: Arthritis, Rheumatoid
Telerehabilitation
controlled randomised trial
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Average DAS28-CRP over time
timeFrame: 6 months from baseline
Secondary outcomes:
measure: DAS28-CRP<3.2
timeFrame: 6 months from baseline
measure: DAS28-CRP<2.6
timeFrame: 6 months from baseline
measure: Remission
timeFrame: 6 months from baseline
measure: The Short Form (36) Health Survey(The SF-36)
timeFrame: Change in the overall scores of the short form 36 questionnaire
measure: Swollen-joint count,
timeFrame: 6 months from baseline
measure: Tender-joint count
timeFrame: 6 months from baseline
measure: Physician's Global Assessment
timeFrame: 6 months from baseline
measure: Patient's Global Assessment
timeFrame: 6 months from baseline
measure: Patient's assessment of pain
timeFrame: 6 months from baseline
measure: HAQ-DI
timeFrame: 6 months from baseline
measure: High-sensitivity C-reactive protein
timeFrame: 6 months from baseline
measure: Erythrocyte sedimentation
timeFrame: 6 months from baseline
measure: Simplified Disease Activity Index
timeFrame: 6 months from baseline
measure: Clinical Disease Activity Index
timeFrame: 6 months from baseline
measure: Rheumatoid Arthritis Impact of Disease (RAID)
timeFrame: 6 months from baseline
measure: Brief illness perception questionnaire (IPQ-B)
timeFrame: 6 months from baseline
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute of Rheumatology, Charles University
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: The Parker Institute
name: Henning Bliddal, DMSc
role: PRINCIPAL_INVESTIGATOR
References: