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

Henrik Gudbergsen

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: instruction; Other: standard baseline instruction

Study type: Interventional

Funder types: Other

Identifiers

NCT02317939

100.01

Details and patient eligibility

About

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

Full 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

Enrollment: 240 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

online instruction at followup visits

Experimental group

Description:

patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home

Treatment:

Other: instruction

standard baseline instruction

Active Comparator group

Description:

after 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

Treatment:

Other: standard baseline instruction