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Completed

NCT Number: NCT02818478

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

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

Completed

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Key information

Conditions

Rheumatoid Arthritis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Reporting of patient reported outcome measures

Other

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

Primary outcomes

  1. HAQ

    Time frame: 48 hours

    The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis

Secondary outcomes

  1. 100 mm VAS global

    Time frame: 48 hours

    Assessed via a visual analogue scale (VAS)

  2. 100 mm VAS pain

    Time frame: 48 hours

    Assessed via a visual analogue scale (VAS)

  3. 100 mm VAS fatigue

    Time frame: 48 hours

    Assessed via a visual analogue scale (VAS)

  4. 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

  5. BASFI

    Time frame: 48 hours

    The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis

  6. BASDAI 5 & 6

    Time frame: 48 hours

    Questions 5 and 6 in BASDAI

Other outcomes

  1. Smoking questionnaire

    Time frame: 48 hours

    Smoking habits (I currently smoke; if smoking, then how many cigarettes, pibes, cigarillos, cigars and/or cheroots per day / I smoke from time to time; less than 1 cigarettes, or an equivalent amount, per day / I have stopped smoking; year of cessation / I have never smoked)

  2. Alcohol consumption (units consumed per week)

    Time frame: 48 hours

  3. Exercise questionnaire

    Time frame: 48 hours

    Level of exercise; "exercise that causes an increased pulse and/or a feeling of being breathless" (5 times per week / 3-4 times per week / 1-2 times per week / 1-2 times per month / no regular exercising / I do not exercise)

  4. Medical conditions questionnaire

    Time frame: 48 hours

    Diagnosis of other medical conditions; "Has a doctor ever said that you have or have had the following diseases?" (hypertension / diabetes / tuberculosis / angina / hypercholesterolemia / heart attack / brain haemorrhage / asthma / psoriasis / chronic bronchitis / osteoporosis / ulcer / liver disease / kidney disease / depression / inflammatory bowel disease or Crohns disease / cancer / multiple sclerosis / thyroid disease)

Sponsors and collaborators

Lead sponsor

Henrik Gudbergsen

Other

Collaborators

  • Rigshospitalet, Denmark
  • The DANBIO registry, Denmark

Registry information

Official study title

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

Acronym: PRO

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Feb 8, 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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