NCT02818478

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

May 23, 2016

Last Update Submit

February 7, 2017

Conditions

Rheumatoid ArthritisAxial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • HAQ

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

    48 hours

Secondary Outcomes (6)

  • 100 mm VAS global

    48 hours

  • 100 mm VAS pain

    48 hours

  • 100 mm VAS fatigue

    48 hours

  • BASDAI

    48 hours

  • BASFI

    48 hours

  • +1 more secondary outcomes

Other Outcomes (4)

  • Smoking questionnaire

    48 hours

  • Alcohol consumption (units consumed per week)

    48 hours

  • Exercise questionnaire

    48 hours

  • +1 more other outcomes

Study Arms (4)

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

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

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

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

Other: Reporting of patient reported outcome measures

Interventions

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

AxSpa; at home firstAxSpa; outpatient clinic firstRA; at home firstRA; outpatient clinic first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidAxial Spondyloarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosis

Study Officials

  • Merete M Hetland, MD.PhD.DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
EU Project Coordinator

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 29, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share