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

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ClinicalTrials.gov Identifier: NCT02317939
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Charles University, Czech Republic
Region Capital Denmark
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: instruction Other: standard baseline instruction Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
Study Start Date : December 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: online instruction at followup visits
patients in this group will be subjected to view video instructions online prior to performing the follow-up joint scoring at home
Other: instruction
online instruction tutorials at followup visits

Active Comparator: standard baseline instruction
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
Other: standard baseline instruction
self-guidance at followup visits




Primary Outcome Measures :
  1. Intrarater reliability of DAS28 done by patients [ Time Frame: Baseline ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317939


Locations
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Denmark
Department of Rheumatology
Frederiksberg, Capital Region, Denmark, 2000
Sponsors and Collaborators
Henrik Gudbergsen
Charles University, Czech Republic
Region Capital Denmark
Investigators
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Study Director: Hennning Bliddal, MD, DMSc Parker RI
Principal Investigator: Henrik R Gudbergsen, MD, PhD Parker RI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henrik Gudbergsen, EU project coordinator, Parker Research Institute
ClinicalTrials.gov Identifier: NCT02317939    
Other Study ID Numbers: 100.01
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases