Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
ELECTOR_I
1 other identifier
interventional
240
1 country
1
Brief Summary
A two-step multi-centre study with 240 rheumatoid arthritis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Dec 2014
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 22, 2017
December 1, 2017
2.8 years
December 8, 2014
December 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Intrarater reliability of DAS28 done by patients
Baseline
Secondary Outcomes (4)
Interrater agreement of DAS28CRP
Baseline
Intrarater reliability of joints counts performed by patients
Baseline
Intrarater reliability of joint scores performed by patients
8 weeks
Inter- and intrarater realiabilty of DAS38
8 weeks
Study Arms (2)
online instruction at followup visits
EXPERIMENTALpatients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home
standard baseline instruction
ACTIVE COMPARATORafter the initial training patients in this group will not be subjected to any subsequent instructions prior to performing the follow-up joint scoring at home
Interventions
online instruction tutorials at followup visits
Eligibility Criteria
You may qualify if:
- Diagnosed with RA ≥ 12 months
- DAS28-CRP \< 5,1
You may not qualify if:
- Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henrik Gudbergsenlead
- Charles University, Czech Republiccollaborator
- Region Capital Denmarkcollaborator
Study Sites (1)
Department of Rheumatology
Frederiksberg, Capital Region, 2000, Denmark
Related Publications (1)
Skougaard M, Bliddal H, Christensen R, Ellegaard K, Nielsen SM, Zavada J, Oreska S, Krogh NS, Holm CC, Hetland ML, Vencovsky J, Rogind H, Taylor PC, Gudbergsen H. Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I). J Rheumatol. 2020 May 1;47(5):658-667. doi: 10.3899/jrheum.181362. Epub 2019 Aug 15.
PMID: 31416921DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hennning Bliddal, MD, DMSc
Parker RI
- PRINCIPAL INVESTIGATOR
Henrik R Gudbergsen, MD, PhD
Parker RI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- EU project coordinator
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 17, 2014
Study Start
December 1, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
December 22, 2017
Record last verified: 2017-12