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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Axial Spondyloarthritis
• Intervention / Treatment: Other: Reporting of patient reported outcome measures

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
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; Electronic 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; 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
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; Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAQ	The Health Assessment Questionnaire (HAQ) developed to retrieve quantitative information on outcomes among patients with rheumatoid arthritis	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100 mm VAS global	Assessed via a visual analogue scale (VAS)	48 hours
100 mm VAS pain	Assessed via a visual analogue scale (VAS)	48 hours
100 mm VAS fatigue	Assessed via a visual analogue scale (VAS)	48 hours
BASDAI	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis	48 hours
BASFI	The Bath Ankylosing Spondylitis Functional Index (BASFI) developed to retrieve quantitative information on outcomes among patients with Ankylosing Spondylitis	48 hours
BASDAI 5 & 6	Questions 5 and 6 in BASDAI	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	48 hours
Alcohol consumption (units consumed per week)		48 hours
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)	48 hours
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)	48 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis; Arthritis, Rheumatoid; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 100.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO