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CompletedNCT02818478PROUpdated Feb 8, 2017

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

An interventional study of Reporting of patient reported outcome measures in Rheumatoid Arthritis and Axial Spondyloarthritis, sponsored by Henrik Gudbergsen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-08.

Sponsored by Henrik Gudbergsen · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 42 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Henrik Gudbergsen is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria

  • Impaired vision
  • Non-Danish speaking
  • No electronic device at home,, tablet or computer
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • 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: Reporting of patient reported outcome measures

  • 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: Reporting of patient reported outcome measures

  • 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: Reporting of patient reported outcome measures

  • 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

    Other: Reporting of patient reported outcome measures

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

06

What researchers measure

Primary outcomes

  1. HAQ

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

    Time frame: 48 hours

Secondary outcomes

  1. 100 mm VAS global

    Assessed via a visual analogue scale (VAS)

    Time frame: 48 hours

  2. 100 mm VAS pain

    Assessed via a visual analogue scale (VAS)

    Time frame: 48 hours

  3. 100 mm VAS fatigue

    Assessed via a visual analogue scale (VAS)

    Time frame: 48 hours

  4. BASDAI

    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis

    Time frame: 48 hours

  5. BASFI

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

    Time frame: 48 hours

  6. BASDAI 5 & 6

    Questions 5 and 6 in BASDAI

    Time frame: 48 hours

Other outcomes

  1. Smoking questionnaire

    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)

    Time frame: 48 hours

  2. Alcohol consumption (units consumed per week)

    Time frame: 48 hours

  3. Exercise questionnaire

    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)

    Time frame: 48 hours

  4. Medical conditions questionnaire

    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)

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02818478
Lead sponsor
Henrik Gudbergsen
Collaborators
The DANBIO registry, Denmark, Rigshospitalet, Denmark
Responsible party
Henrik Gudbergsen (EU Project Coordinator, Parker Research Institute) — Sponsor-investigator
First posted
Jun 29, 2016
Start date
May 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Feb 8, 2017

Study contacts

Merete M Hetland, MD.PhD.DMSc
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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