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Completed

NCT Number: NCT02317939

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology

Frederiksberg, Capital Region, 2000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

instruction

Other

online instruction tutorials at followup visits

standard baseline instruction

Other

self-guidance at followup visits

Primary outcomes

  1. Intrarater reliability of DAS28 done by patients

    Time frame: Baseline

Secondary outcomes

  1. Interrater agreement of DAS28CRP

    Time frame: Baseline

  2. Intrarater reliability of joints counts performed by patients

    Time frame: Baseline

  3. Intrarater reliability of joint scores performed by patients

    Time frame: 8 weeks

  4. Inter- and intrarater realiabilty of DAS38

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Henrik Gudbergsen

Other

Collaborators

  • Charles University, Czech Republic
  • Region Capital Denmark

Registry information

Acronym: ELECTOR_I

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 17, 2014
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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