"Psoriatic arthritis" and "Rheuma"
Conditions
Interventions
The study collects data to develop algorithms.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: At least 18 years of age and competentDiagnosed with PsAUsing s smartphoneAgree to use smartwatchGood command of the local language
Exclusion criteria
Exclusion criteria: Age less than 18 years Incapacitated patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of flare in psoriatic arthritis evaluated every 3 months, defined as: Patients ‘At this time, is your psoriatic arthritis in remission , if this means: you feel your disease is as good as gone?’ ‘At this time, are you in low disease activity, if this means: your disease is in low activity but it’s not as good as gone?’ Doctors ‘At this time, is the psoriatic arthritis in remission, if this means: the absence of clinical and laboratory evidence of significant inflammatory disease activity?’‘At this time, is the psoriatic arthritis in low or minimal disease activity?’* *The study is powered on low or minimal disease activity as noted by the doctor. Patient Acceptable Symptom State (PASS)‘If you were to remain for the next few months as you were during the last 48 hours, would this be acceptable or unacceptable for you?’ yes/ no | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parametersBased on clinical evaluation and the patient reported outcomes the following composites will be calculated: Minimal disease Activity (MDA) Psoriatic Arthritis Disease Activity Score (PASDAS) Disease Activity Psoriatic Arthritis (DAPSA) Likert Scale questions on a daily basis from the Psoriatic Arthritis Impact of Disease (PSAID): Severity of pain (PSAID 1). When in pain, follow-up question: “did you use painkillers or NSAIDs?” Severity of fatigue (PSAID2) Sleep (PSAID 7) 10 point Likert scale for Severity of stiffness (morning stiffness) In addition the following flare questions will be asked at baseline, follow-up visits, and when patients experience disease flare in which they seek help from the rheumatologist: Doctors‘At this time, is the disease in flare (i.e., significantly worsened/more active compared to usual)?’ yes/no Patients ‘At this time, are you having a flare of your psoriatic arthritis, if this means the symptoms are worse than usual?’ yes/no Other study parameters Phone capturedKeypad time-related data and metadata Accelerometer and gyroscope sensor data Screen time Hand and feet photos Hand, gesture and posture videos (no raw videos will be stored) Smart watch capturedSleeping time and typeAccelerometer data Screen time Body battery / Stress levels Heart rate and Beat-to-beat intervals Motion intensity Pulse Ox Steps Physical activity intensity and categories as captured by the device Distance The digital parameters will be provided as raw data from Garmin (e.g., heart rate) or if they are calculated from other parameters (e.g., respiration rate) as determined by Garmin. Clinical assessment Medical history Age Sex Years of disease Medication over the year of the study Comorbidity Care activities Job title, shift work and frequent flying Handedness | — |
Countries
Greece, Netherlands, Portugal, United Kingdom
Contacts
Public ContactB Hojeij
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed