Rheumatoid ArthritisPRONCT02818478
Patient Reported Outcomes Reported Via PC / Tablet Home Versus Touch Screen at Hospital Among Patients With Arthritis
A study testing Reporting of patient reported outcome measures in people with Rheumatoid Arthritis and Axial Spondyloarthritis, run by Henrik Gudbergsen.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Axial Spondyloarthritis
- What is being tested?
- Reporting of patient reported outcome measures
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Impaired vision
- Non-Danish speaking
- No electronic device at home,, tablet or computer
About this study
Official 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
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
- Conditions
- Rheumatoid Arthritis, Axial Spondyloarthritis
- Being tested
- Reporting of patient reported outcome measures
- Medical subject headings
- Arthritis, Rheumatoid, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reporting of patient reported outcome measuresOther
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| RA; at home first | Other | 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 Receives: Other: Reporting of patient reported outcome measures |
| RA; outpatient clinic first | Other | 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 Receives: Other: Reporting of patient reported outcome measures |
| AxSpa; at home first | Other | 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 Receives: Other: Reporting of patient reported outcome measures |
| AxSpa; outpatient clinic first | Other | 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 Receives: Other: Reporting of patient reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAQ
The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis
Measured: 48 hours
Secondary outcomes (6)
100 mm VAS global
Assessed via a visual analogue scale (VAS)
Measured: 48 hours
100 mm VAS pain
Assessed via a visual analogue scale (VAS)
Measured: 48 hours
100 mm VAS fatigue
Assessed via a visual analogue scale (VAS)
Measured: 48 hours
BASDAI
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
Measured: 48 hours
BASFI
The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
Measured: 48 hours
BASDAI 5 & 6
Questions 5 and 6 in BASDAI
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Gudbergsen
- Sponsor type
- University, hospital or other
- Collaborators
- The DANBIO registry, Denmark, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Henrik Gudbergsen, Parker Research Institute
- Investigators
- Merete M Hetland, MD.PhD.DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818478
- Sponsor's protocol ID
- 100.03
- Acronym
- PRO
- Status last verified
- Feb 2017
- First submitted
- 23 May 2016
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02818478
- Acronym / sponsor ID
- PRO / 100.03
- Conditions
- Rheumatoid Arthritis, Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Henrik GudbergsenUniversity, hospital or other
- Collaborators
- The DANBIO registry, Denmark, Copenhagen University Hospital, Rigshospitalet
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RA; at home first | Other | Other: Reporting of patient reported outcome measuresPatients 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 |
| RA; outpatient clinic first | Other | Other: Reporting of patient reported outcome measuresPatients 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 |
| AxSpa; at home first | Other | Other: Reporting of patient reported outcome measuresPatients 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 |
| AxSpa; outpatient clinic first | Other | Other: Reporting of patient reported outcome measuresPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Impaired vision
- Non-Danish speaking
- No electronic device at home,, tablet or computer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reporting of patient reported outcome measuresElectronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic | Other | AxSpa; at home first, AxSpa; outpatient clinic first, RA; at home first, RA; outpatient clinic first |
Primary outcome
HAQ
Time frame: 48 hours
The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis
6 secondary outcomes
100 mm VAS global
Time frame: 48 hours
100 mm VAS pain
Time frame: 48 hours
100 mm VAS fatigue
Time frame: 48 hours
BASDAI
Time frame: 48 hours
BASFI
Time frame: 48 hours
BASDAI 5 & 6
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete M Hetland, MD.PhD.DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Reporting of patient reported outcome measures in people with Rheumatoid Arthritis and Axial Spondyloarthritis, run by Henrik Gudbergsen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAQ (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.