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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Telerehabilitation, Arthritis, Rheumatoid

Intervention / Treatment
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* Device: Homebased disease monitoring (eHealth)
* Other: Standard clinical disease monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homebased disease monitoring (eHealth)<br>Participants allocated to the intervention group will be trained in self-monitoring of their RA | Device: Homebased disease monitoring (eHealth)<br>* 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.<br>|
| Active Comparator: Standard clinical disease monitoring<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28-CRP<3.2 | Proportion of patients with low disease activity (LDA) defined as DAS28-CRP<3.2 | 6 months from baseline | 
| DAS28-CRP<2.6 | Proportion of patients in remission defined as DAS28-CRP<2.6 | 6 months from baseline | 
| Remission | Proportion of patients fulfilling the provisional and adapted ACR/EULAR remission criteria | 6 months from baseline | 
| The Short Form (36) Health Survey(The SF-36) | Change in the overall scores of the short form 36 questionnaire. The SF-36 is a patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | Change in the overall scores of the short form 36 questionnaire | 
| Swollen-joint count, | Swollen-joint count, of 28 joints examined | 6 months from baseline | 
| Tender-joint count | Tender-joint count, of 28 joints examined | 6 months from baseline | 
| Physician's Global Assessment | Physician's Global Assessment - 0-100 mm VAS | 6 months from baseline | 
| Patient's Global Assessment | Patient's Global Assessment - 0-100 mm VAS | 6 months from baseline | 
| Patient's assessment of pain | Patient's assessment of pain - 0-100 mm VAS | 6 months from baseline | 
| HAQ-DI | HAQ-DI - score: 0-3 | 6 months from baseline | 
| High-sensitivity C-reactive protein | High-sensitivity C-reactive protein - mg/L | 6 months from baseline | 
| Erythrocyte sedimentation | Erythrocyte sedimentation - mm/hr | 6 months from baseline | 
| Simplified Disease Activity Index | Simplified Disease Activity Index - score 0.1 to 86.0 | 6 months from baseline | 
| Clinical Disease Activity Index | Clinical Disease Activity Index - score 0 to 76 | 6 months from baseline | 
| Rheumatoid Arthritis Impact of Disease (RAID) | 7 (NRS) questions assessed as a number between 0 and 10. | 6 months from baseline | 
| Brief illness perception questionnaire (IPQ-B) | Generic questionnaire developed to measure illness perception. The IPQ-B contains eight items and one causal scale. Items 1-8 are rated using a 0-to-10 response scale, item 9 is a memo field. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). A low score on items number 1,2,5,6 and 8 indicates that the illness is perceived as benign while a low score on the items 3, 4 and 7 indicates that the illness is perceived as threatening. By reversing these three items it is possible to compute an overall score. A higher score reflects a more threatening view of the illness. | 6 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Rheumatoid, Telerehabilitation, controlled randomised trial