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

Primary Purpose

Rheumatoid Arthritis, Axial Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reporting of patient reported outcome measures
Sponsored by
Henrik Gudbergsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    RA; at home first

    RA; outpatient clinic first

    AxSpa; at home first

    AxSpa; outpatient clinic first

    Arm Description

    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

    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

    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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    100 mm VAS global
    Assessed via a visual analogue scale (VAS)
    100 mm VAS pain
    Assessed via a visual analogue scale (VAS)
    100 mm VAS fatigue
    Assessed via a visual analogue scale (VAS)
    BASDAI
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
    BASFI
    The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
    BASDAI 5 & 6
    Questions 5 and 6 in BASDAI

    Full Information

    First Posted
    May 23, 2016
    Last Updated
    February 7, 2017
    Sponsor
    Henrik Gudbergsen
    Collaborators
    The DANBIO registry, Denmark, Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02818478
    Brief Title
    Patient Reported Outcomes Reported Via PC / Tablet Home Versus Touch Screen at Hospital Among Patients With Arthritis
    Acronym
    PRO
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Henrik Gudbergsen
    Collaborators
    The DANBIO registry, Denmark, Rigshospitalet, Denmark

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis, Axial Spondyloarthritis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RA; at home first
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    RA; outpatient clinic first
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    AxSpa; at home first
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    AxSpa; outpatient clinic first
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Reporting of patient reported outcome measures
    Intervention Description
    Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
    Primary Outcome Measure Information:
    Title
    HAQ
    Description
    The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    100 mm VAS global
    Description
    Assessed via a visual analogue scale (VAS)
    Time Frame
    48 hours
    Title
    100 mm VAS pain
    Description
    Assessed via a visual analogue scale (VAS)
    Time Frame
    48 hours
    Title
    100 mm VAS fatigue
    Description
    Assessed via a visual analogue scale (VAS)
    Time Frame
    48 hours
    Title
    BASDAI
    Description
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
    Time Frame
    48 hours
    Title
    BASFI
    Description
    The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis
    Time Frame
    48 hours
    Title
    BASDAI 5 & 6
    Description
    Questions 5 and 6 in BASDAI
    Time Frame
    48 hours
    Other Pre-specified Outcome Measures:
    Title
    Smoking questionnaire
    Description
    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
    Title
    Alcohol consumption (units consumed per week)
    Time Frame
    48 hours
    Title
    Exercise questionnaire
    Description
    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
    Title
    Medical conditions questionnaire
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merete M Hetland, MD.PhD.DMSc
    Organizational Affiliation
    Rigshospitalet, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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