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

NCT03486613 | Completed

• 1 other identifier: 2018-000367
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Health Assessment Questionnaire (HAQ)

  Assess the patient's physical function

  day 1 (first data registration) and day 3 (second data registration)

Secondary Outcomes (9)

• Visual Analogue Scale for Pain

  day 1 (first data registration) and day 3 (second data registration)

• Visual Analogue Scale for fatigue

  day 1 (first data registration) and day 3 (second data registration)

• Patient Global Visual Analogue Scale

  day 1 (first data registration) and day 3 (second data registration)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  day 1 (first data registration) and day 3 (second data registration)

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  day 1 (first data registration) and day 3 (second data registration)

Study Arms (2)

Group AT

OTHER

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; Other: PROM registration via the touch screen solution

Group TA

OTHER

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

Other: PROM registration via the DANBIO App on a smartphone; Other: PROM registration via the touch screen solution

Interventions

PROM registration via the DANBIO App on a smartphone OTHER

PROM data is reported through the DANBIO smartphone app

Group AT; Group TA

PROM registration via the touch screen solution OTHER

PROM data is reported through the touch screen solution

Group AT; Group TA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salome Kristensen: lead

Study Sites (1)

Department of Rheumatology

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis

Study Officials

• Salome Kristensen, MD, PhD

  Department of Rheumatology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: A randomised, within-participants, open, cross-over design trial

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: April 3, 2018
• Study Start: April 24, 2019
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)