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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03428763
• Date of registration: 05/02/2018
• Prospective Registration: Yes
• Primary sponsor: Frederiksberg University Hospital
• Public title: ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: August 18, 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03428763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Czechia, Denmark, United Kingdom

Contacts

• Name: Henning Bliddal, DMSc
• Affiliation: The Parker Institute

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Telerehabilitation

Intervention(s)

Device: Homebased disease monitoring (eHealth)

Other: Standard clinical disease monitoring

Primary Outcome(s)

Average DAS28-CRP over time [Time Frame: 6 months from baseline]

Secondary Outcome(s)

DAS28-CRP<2.6 [Time Frame: 6 months from baseline]

High-sensitivity C-reactive protein [Time Frame: 6 months from baseline]

DAS28-CRP<3.2 [Time Frame: 6 months from baseline]

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

Simplified Disease Activity Index [Time Frame: 6 months from baseline]

Clinical Disease Activity Index [Time Frame: 6 months from baseline]

Patient's assessment of pain [Time Frame: 6 months from baseline]

Remission [Time Frame: 6 months from baseline]

Swollen-joint count, [Time Frame: 6 months from baseline]

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

HAQ-DI [Time Frame: 6 months from baseline]

Erythrocyte sedimentation [Time Frame: 6 months from baseline]

Tender-joint count [Time Frame: 6 months from baseline]

Patient's Global Assessment [Time Frame: 6 months from baseline]

Physician's Global Assessment [Time Frame: 6 months from baseline]

Rheumatoid Arthritis Impact of Disease (RAID) [Time Frame: 6 months from baseline]

Secondary ID(s)

APPI-100.02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors