PROM Collected Via a Smartphone App Versus a Touch Screen Solution Among Patients With Inflammatory Arthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis
• Intervention / Treatment: Other: PROM registration via the DANBIO App on a smartphone; Other: PROM registration via the touch screen solution

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of rheumatology

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group AT; PROM registration via the DANBIO App on a smartphone and thereafter the touch screen solution	Other: PROM registration via the DANBIO App on a smartphone; PROM data is reported through the DANBIO smartphone app; Other: PROM registration via the touch screen solution; PROM data is reported through the touch screen solution
Other: Group TA; PROM registration via the touch screen solution and thereafter the DANBIO App	Other: PROM registration via the DANBIO App on a smartphone; PROM data is reported through the DANBIO smartphone app; Other: PROM registration via the touch screen solution; PROM data is reported through the touch screen solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Assessment Questionnaire (HAQ)	Assess the patient's physical function	day 1 (first data registration) and day 3 (second data registration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for Pain	The patient's assessment of pain on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of pain and the right end (100) maximum pain.	day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for fatigue	The patient's assessment of fatigue on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of fatigue and the right end (100) maximum fatigue.	day 1 (first data registration) and day 3 (second data registration)
Patient Global Visual Analogue Scale	The patient's global assessment of disease activity (arthritis severity) on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of arthritis activity and the right end (100) maximum arthritis activity.	day 1 (first data registration) and day 3 (second data registration)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The patient's assessment of essential symptoms in axial arthritis. The questionnaire consist of six questions regarding essential symptoms in axial arthritis answered on a Visual Analogue Scale from 0-100. The left of the scale (0) signifies the absence of symptoms and the right end (100) maximum symptoms. The patient's answer for each individual question are added to a combined score of 0-100, where 0 signifies the absence of symptoms and 100 maximum symptoms.	day 1 (first data registration) and day 3 (second data registration)
Bath Ankylosing Spondylitis Functional Index (BASFI)	The patient's assesment of physical function. The questionnaire consist of ten questions regarding physical function in axial arthritis answered on a Visual Analogue Scale from 0-100. The left of the scale (0) signifies the absence of physical limitations and the right end (100) maximum physical limitations. The patient's answer for each individual question are added to a combined score of 0-100, where 0 signifies the absence physical limitations and 100 maximum physical limitations.	day 1 (first data registration) and day 3 (second data registration)
Patient Acceptable Symptom State (PASS)	The patient's assessment of acceptable symptom state. Consist of one question answered with "yes" or "no". The question is: ''Take into account all the ways in which your arthritis has affected you in the past 48 hours. If you were to remain for the next few months as you are today, would it be acceptable to you?"	day 1 (first data registration) and day 3 (second data registration)
Anchoring question	The patient's assessment of change in arthritis activity since last visit	day 1 (first data registration) and day 3 (second data registration)
Disease Activity Score 28 joints C-reactive protein (DAS28crp)	Composite score used as a measurement of disease activity in patients with peripheral arthritis. The DAS28crp score is based on 28 joint count for tenderness (TJC28) and swelling (SJC28), Patient Global Visual Analogue Scale (GH) and CRP level (CRP). The DAS28crp equation is: DAS28crp = 0.56square root(TJC28) + 0.28square root(SJC28) + 0.36ln(CRP + 1) + 0.014(GH) + 0.96. ASDAS = 0.12*Back Pain + 0.06*Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*Ln(CRP+1)0.96-9.4 where a score under 2.6 is remission, a score between 2.6-3.1 is low disease activity, a score of 3.2-5.1 is moderate disease activity and a score of 5.1 or higher is high disease activity.	day 1 (first data registration) and day 3 (second data registration)
Ankylosing Spondylitis Disease Activity Score (ASDAS)	Composite score used as a measurement of disease activity in patients with axial arthritis. The ASDAS score is based on some of the questions from the BASDAI questionnaire and C-reative protein (CRP). The ASDAS equation is: ASDAS = 0.12*Back Pain + 0.06*Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*Ln(CRP+1). The scale ranges from 0.6 to infinite where a score under 1.3 is remission, a score between 1.3-2.0 is moderate disease activity, a score of 2.1-3.5 is high disease activity and a score of higher than 3.5 is very high disease activity.	day 1 (first data registration) and day 3 (second data registration)

Collaborators and Investigators

• Sponsor: Salome Kristensen
• Investigators: Principal Investigator: Salome Kristensen, MD, PhD, Department of Rheumatology, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: April 1, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Arthritis; Arthritis, Psoriatic; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 2018-000367

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No