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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02818478
Acronym
PRO
Enrollment
42
Registered
2016-06-29
Start date
2016-05-31
Completion date
2016-12-31
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis, Rheumatoid Arthritis

Brief summary

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

Interventions

OTHERReporting 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

Sponsors

The DANBIO registry, Denmark
CollaboratorUNKNOWN
Rigshospitalet, Denmark
CollaboratorOTHER
Henrik Gudbergsen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HAQ48 hoursThe Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis

Secondary

MeasureTime frameDescription
100 mm VAS global48 hoursAssessed via a visual analogue scale (VAS)
100 mm VAS pain48 hoursAssessed via a visual analogue scale (VAS)
100 mm VAS fatigue48 hoursAssessed via a visual analogue scale (VAS)
BASDAI48 hoursThe Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
BASDAI 5 & 648 hoursQuestions 5 and 6 in BASDAI
BASFI48 hoursThe Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis

Other

MeasureTime frameDescription
Exercise questionnaire48 hoursLevel 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)
Medical conditions questionnaire48 hoursDiagnosis 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)
Alcohol consumption (units consumed per week)48 hours
Smoking questionnaire48 hoursSmoking 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026