Patient Reported Outcomes Reported Via PC / Tablet Home Versus Touch Screen at Hospital Among Patients With Arthritis

Overview

To investigate if electronic reporting of patient reported outcome measures from home is comparable to the traditional touch-screen solution to hospital among patients with rheumatoid arthritis and axial spondyloarthritis

Full Title of Study: “Patient Reported Outcome Measures Reported Into the Danish Arthritis Registry (DANBIO) Via Computer or Tablet at Home Versus Touch Screen at the Outpatient Clinic Among Patients With Axial Spondyloarthritis or Rheumatoid Arthritis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2016

Interventions

  • Other: Reporting of patient reported outcome measures
    • Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

Arms, Groups and Cohorts

  • Other: RA; at home first
    • Patients in this arm (10 patients with rheumatoid arthirtis, RA) will be randomised to initially fill in patient reported outcome measures from home via their own computer or tablet; subsequently these patients will fill in patient reported outcome measures at the outpatient clinic
  • Other: RA; outpatient clinic first
    • Patients in this arm (10 patients with rheumatoid arthirtis, RA) will be randomised to initially fill in patient reported outcome measures at the outpatient clinic; subsequently these patients will fill in patient reported outcome measures from home via their own computer or tablet
  • Other: AxSpa; at home first
    • Patients in this arm (10 patients with axial spondyloarthritis, AxSpa) will be randomised to initially fill in patient reported outcome measures from home via their own computer or tablet; subsequently these patients will fill in patient reported outcome measures at the outpatient clinic
  • Other: AxSpa; outpatient clinic first
    • Patients in this arm (10 patients with axial spondyloarthritis, AxSpa) will be randomised to initially fill in patient reported outcome measures at the outpatient clinic; subsequently these patients will fill in patient reported outcome measures from home via their own computer or tablet

Clinical Trial Outcome Measures

Primary Measures

  • HAQ
    • Time Frame: 48 hours
    • The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis

Secondary Measures

  • 100 mm VAS global
    • Time Frame: 48 hours
    • Assessed via a visual analogue scale (VAS)
  • 100 mm VAS pain
    • Time Frame: 48 hours
    • Assessed via a visual analogue scale (VAS)
  • 100 mm VAS fatigue
    • Time Frame: 48 hours
    • Assessed via a visual analogue scale (VAS)
  • BASDAI
    • Time Frame: 48 hours
    • The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
  • BASFI
    • Time Frame: 48 hours
    • The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
  • BASDAI 5 & 6
    • Time Frame: 48 hours
    • Questions 5 and 6 in BASDAI

Participating in This Clinical Trial

Inclusion Criteria

  • Rheumatoid arthirtis OR axial spondyloarthritis – Active treatment and monitoring of the Knowledge Center for Rheumatology and Spine diseases, Rigshospitalet, Denmark – Patients must have reported patient reported outcome measures via DANBIOs touch-screen solution ≥ 3 times Exclusion Criteria – Impaired vision – Non-Danish speaking – No electronic device at home,, tablet or computer

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henrik Gudbergsen
  • Collaborator
    • The DANBIO registry, Denmark
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Henrik Gudbergsen, EU Project Coordinator – Parker Research Institute
  • Overall Official(s)
    • Merete M Hetland, MD.PhD.DMSc, Principal Investigator, Rigshospitalet, Denmark

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