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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428763
Recruitment Status : Withdrawn (Technical problems with POC)
First Posted : February 12, 2018
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital

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).

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Telerehabilitation Device: Homebased disease monitoring (eHealth) Other: Standard clinical disease monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 18, 2020
Actual Primary Completion Date : August 18, 2020
Actual Study Completion Date : August 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Homebased disease monitoring (eHealth)
Participants allocated to the intervention group will be trained in self-monitoring of their RA
Device: 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.

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Average DAS28-CRP over time [ Time Frame: 6 months from baseline ]
    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.


Secondary Outcome Measures :
  1. DAS28-CRP<3.2 [ Time Frame: 6 months from baseline ]
    Proportion of patients with low disease activity (LDA) defined as DAS28-CRP<3.2

  2. DAS28-CRP<2.6 [ Time Frame: 6 months from baseline ]
    Proportion of patients in remission defined as DAS28-CRP<2.6

  3. Remission [ Time Frame: 6 months from baseline ]
    Proportion of patients fulfilling the provisional and adapted ACR/EULAR remission criteria

  4. The Short Form (36) Health Survey(The SF-36) [ Time Frame: Change in the overall scores of the short form 36 questionnaire ]

    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.


  5. Swollen-joint count, [ Time Frame: 6 months from baseline ]
    Swollen-joint count, of 28 joints examined

  6. Tender-joint count [ Time Frame: 6 months from baseline ]
    Tender-joint count, of 28 joints examined

  7. Physician's Global Assessment [ Time Frame: 6 months from baseline ]
    Physician's Global Assessment - 0-100 mm VAS

  8. Patient's Global Assessment [ Time Frame: 6 months from baseline ]
    Patient's Global Assessment - 0-100 mm VAS

  9. Patient's assessment of pain [ Time Frame: 6 months from baseline ]
    Patient's assessment of pain - 0-100 mm VAS

  10. HAQ-DI [ Time Frame: 6 months from baseline ]
    HAQ-DI - score: 0-3

  11. High-sensitivity C-reactive protein [ Time Frame: 6 months from baseline ]
    High-sensitivity C-reactive protein - mg/L

  12. Erythrocyte sedimentation [ Time Frame: 6 months from baseline ]
    Erythrocyte sedimentation - mm/hr

  13. Simplified Disease Activity Index [ Time Frame: 6 months from baseline ]
    Simplified Disease Activity Index - score 0.1 to 86.0

  14. Clinical Disease Activity Index [ Time Frame: 6 months from baseline ]
    Clinical Disease Activity Index - score 0 to 76

  15. Rheumatoid Arthritis Impact of Disease (RAID) [ Time Frame: 6 months from baseline ]
    7 (NRS) questions assessed as a number between 0 and 10.

  16. Brief illness perception questionnaire (IPQ-B) [ Time Frame: 6 months from baseline ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428763


Locations
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Czechia
Institute of Rheumatology, Charles University
Prague, Czechia, 128 50
Denmark
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000
United Kingdom
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Windmill Road, Headington, Oxford, OX3 7LD, United Kingdom
Oxford, Headington, Oxford, United Kingdom, OX3 7LD
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
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Principal Investigator: Henning Bliddal, DMSc The Parker Institute
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Responsible Party: Henning Bliddal, Head of the Parker Institute, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT03428763    
Other Study ID Numbers: APPI-100.02
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henning Bliddal, Frederiksberg University Hospital:
Arthritis, Rheumatoid
Telerehabilitation
controlled randomised trial
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases