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

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ClinicalTrials.gov Identifier: NCT02818478
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : February 8, 2017
Sponsor:
Collaborators:
The DANBIO registry, Denmark
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Axial Spondyloarthritis Other: Reporting of patient reported outcome measures Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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 Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

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
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

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
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

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
Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic




Primary Outcome Measures :
  1. HAQ [ Time Frame: 48 hours ]
    The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis


Secondary Outcome Measures :
  1. 100 mm VAS global [ Time Frame: 48 hours ]
    Assessed via a visual analogue scale (VAS)

  2. 100 mm VAS pain [ Time Frame: 48 hours ]
    Assessed via a visual analogue scale (VAS)

  3. 100 mm VAS fatigue [ Time Frame: 48 hours ]
    Assessed via a visual analogue scale (VAS)

  4. BASDAI [ Time Frame: 48 hours ]
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis

  5. BASFI [ Time Frame: 48 hours ]
    The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis

  6. BASDAI 5 & 6 [ Time Frame: 48 hours ]
    Questions 5 and 6 in BASDAI


Other Outcome Measures:
  1. Smoking questionnaire [ Time Frame: 48 hours ]
    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)

  2. Alcohol consumption (units consumed per week) [ Time Frame: 48 hours ]
  3. Exercise questionnaire [ Time Frame: 48 hours ]
    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)

  4. Medical conditions questionnaire [ Time Frame: 48 hours ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818478


Sponsors and Collaborators
Henrik Gudbergsen
The DANBIO registry, Denmark
Rigshospitalet, Denmark
Investigators
Principal Investigator: Merete M Hetland, MD.PhD.DMSc Rigshospitalet, Denmark

Responsible Party: Henrik Gudbergsen, EU Project Coordinator, Parker Research Institute
ClinicalTrials.gov Identifier: NCT02818478     History of Changes
Other Study ID Numbers: 100.03
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylitis
Spinal Diseases
Bone Diseases