Clinical trial NCT03486613: PROM Collected Via a Smartphone App Versus a Touch Screen Solution Among Patients With Inflammatory Arthritis
Official title: Patient-reported Outcome Measures Collected in DANBIO Reported Via a Smartphone App Versus a Touch Screen Solution in an Outpatient Clinic Among Patients With Inflammatory Arthritis: A Randomised Cross-over Agreement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Axial Spondyloarthritis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomised, within-participants, open, cross-over design trial
Primary purpose: OTHER

Brief summary: A randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO app on a smartphone first and thereafter via the touch screen solution at the rheumatology outpatient clinic or vice versa. Outcomes are the following PROM: HAQ, VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS.

Detailed description: The study is a randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis (RA) (20), psoriatic arthritis (PsA) (20) and axial spondyloarthritis (SpA) (20) from the Rheumatology outpatient clinic at Aalborg University Hospital. The participants will be randomised in ratio 1:1 to:

* Group AT (App → Touch) (30 participants) the participant reports data through the DANBIO app on a smartphone first and after a "washout period" of one day via the touch screen solution at the rheumatology outpatient clinic.
* Group TA (Touch → App) (30 participants): the participant reports data through the touch screen solution at the rheumatology outpatient clinic and after a "washout period" of one day via the DANBIO app on a smartphone.

The primary objective is to evaluate whether electronic reporting of PROM through the DANBIO smartphone app is comparable to the traditional touch screen solution in the rheumatology outpatient clinic among patients with inflammatory arthritis in standard clinical care. The primary outcome is HAQ. Secondary outcomes are: VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS. DAS28crp are estimated using a fixed level for C-reactive protein (CRP) level of 6, swollen joint count of 0.5 and tender joint count of 1. ASDAS are estimated using a fixed level for CRP of 6. These data are based on DANBIO registrations of patients with RA, PsA or SpA from the rheumatology outpatient clinic at Aalborg University Hospital. DAS28crp and ASDAS are estimated from the PROM data to give the clinician an overview of PROM correlating to e.g. remission or high disease activity.

Eligibility criteria: Inclusion Criteria:

A participant will be eligible for study participation if he/she meets the following criteria:

* Diagnosed in DANBIO with RA, PsA or SpA
* Is currently treated and monitored at the rheumatology outpatient clinic at Aalborg University Hospital
* Have previously reported PROM in DANBIO through the touch screen solution at the rheumatology outpatient clinic ≥ 3 times

Exclusion Criteria:

A participant cannot be included in the study if he/she meets any of the following criteria:

* Inability to provide informed consent or unwilling to comply with the study protocol
* Diagnosis of RA, PsA or SpA ≤ 12 months
* Does not have access to a smartphone that can download and run the DANBIO app
* Not able to understand written Danish i.e. cannot understand the Danish version of the PROM questionnaires
* Reduced sight in such degree that the participant cannot read the questionnaire in the smartphone app/on the touch-screen with e.g. glasses

Primary outcomes:
measure: Change in Health Assessment Questionnaire (HAQ)
timeFrame: day 1 (first data registration) and day 3 (second data registration)
Secondary outcomes:
measure: Visual Analogue Scale for Pain
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Visual Analogue Scale for fatigue
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Patient Global Visual Analogue Scale
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Patient Acceptable Symptom State (PASS)
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Anchoring question
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Disease Activity Score 28 joints C-reactive protein (DAS28crp)
timeFrame: day 1 (first data registration) and day 3 (second data registration)
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: day 1 (first data registration) and day 3 (second data registration)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Rheumatology
Study officials:
affiliation: Department of Rheumatology, Aalborg University Hospital
name: Salome Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: