An interventional study of PROM registration via the DANBIO App on a smartphone and PROM registration via the touch screen solution in Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis, sponsored by Salome Kristensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by Salome Kristensen · Not applicable, Interventional, and Other
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.
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:
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 60 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Salome Kristensen is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A participant will be eligible for study participation if he/she meets the following criteria:
Exclusion Criteria:
A participant cannot be included in the study if he/she meets any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
PROM data is reported through the DANBIO smartphone app
PROM data is reported through the touch screen solution
Change in Health Assessment Questionnaire (HAQ)
Assess the patient's physical function
Time frame: day 1 (first data registration) and day 3 (second data registration)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?"
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: day 1 (first data registration) and day 3 (second data registration)
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Salome Kristensen