Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study

Rheumatoid Arthritis Clinical Trial

— ELECTOR_I  

Official title:

Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317939
• Other study ID #: 100.01
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: December 20, 2017
• Start date: December 2014
• Est. completion date: September 2017

Study information

• Verified date: December 2017
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A two-step multi-centre study with 240 rheumatoid arthritis patients.

Description:

A two-step multi-centre study containing:

A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data

AND

An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosed with RA = 12 months

• DAS28-CRP < 5,1

Exclusion Criteria:

• Dementia or other linguistic/cognitive/physical deficiency that prevents participation

• Vision impairment that prevents the use of the devices and computer

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• instruction
online instruction tutorials at followup visits
• standard baseline instruction
self-guidance at followup visits

Locations

Country	Name	City	State
Denmark	Department of Rheumatology	Frederiksberg	Capital Region

Sponsors (3)

Lead Sponsor	Collaborator
Henrik Gudbergsen	Charles University, Czech Republic, Region Capital Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrarater reliability of DAS28 done by patients		Baseline
Secondary	Interrater agreement of DAS28CRP		Baseline
Secondary	Intrarater reliability of joints counts performed by patients		Baseline
Secondary	Intrarater reliability of joint scores performed by patients		8 weeks
Secondary	Inter- and intrarater realiabilty of DAS38		8 weeks