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

• ClinicalTrials.gov Identifier: NCT03486613
• Recruitment Status: Completed
• First Posted: April 3, 2018
• Last Update Posted: October 2, 2019
• Sponsor: Salome Kristensen
• Information provided by (Responsible Party): Salome Kristensen, Aalborg University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis	Other: PROM registration via the DANBIO App on a smartphone; Other: PROM registration via the touch screen solution	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A randomised, within-participants, open, cross-over design trial
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: April 24, 2019
• Actual Primary Completion Date: September 12, 2019
• Actual Study Completion Date: September 12, 2019

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Change in Health Assessment Questionnaire (HAQ) [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   Assess the patient's physical function

Secondary Outcome Measures :

1. Visual Analogue Scale for Pain [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.
2. Visual Analogue Scale for fatigue [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.
3. Patient Global Visual Analogue Scale [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.
4. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.
5. Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.
6. Patient Acceptable Symptom State (PASS) [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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?"
7. Anchoring question [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   The patient's assessment of change in arthritis activity since last visit
8. Disease Activity Score 28 joints C-reactive protein (DAS28crp) [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.
9. Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: day 1 (first data registration) and day 3 (second data registration) ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Denmark

Department of Rheumatology

Aalborg, Denmark, 9000

Sponsors and Collaborators

Salome Kristensen

Investigators

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

More Information

• Responsible Party: Salome Kristensen, MD, PhD, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT03486613
• Other Study ID Numbers: 2018-000367
• First Posted: April 3, 2018
• Last Update Posted: October 2, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Spondylarthritis; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases