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

NCT ID: NCT03486613

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2019-09-12

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group AT

PROM registration via the DANBIO App on a smartphone and thereafter the touch screen solution

Group Type: OTHER

PROM registration via the DANBIO App on a smartphone

Intervention Type: OTHER

PROM data is reported through the DANBIO smartphone app

PROM registration via the touch screen solution

Intervention Type: OTHER

PROM data is reported through the touch screen solution

Group TA

PROM registration via the touch screen solution and thereafter the DANBIO App

Group Type: OTHER

PROM registration via the DANBIO App on a smartphone

Intervention Type: OTHER

PROM data is reported through the DANBIO smartphone app

PROM registration via the touch screen solution

Intervention Type: OTHER

PROM data is reported through the touch screen solution

Interventions

PROM registration via the DANBIO App on a smartphone

PROM data is reported through the DANBIO smartphone app

Intervention Type: OTHER

PROM registration via the touch screen solution

PROM data is reported through the touch screen solution

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salome Kristensen

OTHER

Sponsor Role: lead

Responsible Party

Salome Kristensen

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Salome Kristensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology, Aalborg University Hospital

Locations

Department of Rheumatology

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

2018-000367

Identifier Type: -

Identifier Source: org_study_id