An observational study in Psoriatic Arthritis, Flare Up, Symptom and Psoriatic Arthritis Aggravated, sponsored by Jolanda Luime. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Jolanda Luime · Observational
The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:
Participants will be requested to:
594 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.
This study's planned enrollment of 600 is above the median of 300 across 243 observational studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →This is the only study on the registry with Jolanda Luime as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with psoriatic arthritis
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.
Exclusion Criteria:
Absence of flare in patients
Flare in psoriatic arthritis evaluated as: Patients * 'At this time, is your psoriatic arthritis in remission, if this means: you feel your disease is as good as gone?' yes/ no (for remission) * '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?' yes/ no (for low disease activity) Patient Acceptable Symptom State \- '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 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?' yes/ no (for remission) * 'At this time, is the psoriatic arthritis in low or minimal disease activity?' yes/ no (for low disease activity)
Time frame: 12 months (follow-up every 3 months)
Minimal disease Activity (MDA)
MDA as defined by patient meeting 5 out of 7 of the following criteria: (i) tender joint count ≤1; (ii) swollen joint count ≤1; (iii) Psoriasis Area and Severity Index ≤ 1 or body surface area ≤3%; (iv) tender entheseal points ≤ 1 (v) patient pain visual analogue scale VAS ≤15; (vi) patient global activity VAS ≤20; (vii) Health Assessment Questionnaire (HAQ) ≤0.5
Time frame: 12 months (follow-up every 3 months)
Psoriatic Arthritis Disease Activity Score (PASDAS)
PASDAS calculated as a composite score using the following criteria: physician global VAS, patient global VAS, SF36 physical (PCS), swollen joint count, tender joint count, Leeds Enthesitis Index, tender dactylitis count, and CRP. Higher scores indicate higher disease activity.
Time frame: 12 months (follow-up every 3 months)
Disease Activity Psoriatic Arthritis (DAPSA)
DAPSA calculated as a summation score of the following: tender and swollen joints, patient global assessment VAS, patient pain VAS and C-reactive protein. Higher scores indicate higher disease activity.
Time frame: 12 months (follow-up every 3 months)
Psoriatic Arthritis Impact of Disease (PsAID)
PsAID:10-point Likert scale questions on 12 items (pain, fatigue, skin, work/leisure activities, functional capacity, discomfort, sleep, coping, anxiety, embarrassment, social life, depression). Higher score indicates higher impact of disease.
Time frame: 12 months (follow-up every 3 months)
Morning stiffness
Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.
Time frame: 12 months (follow-up every 3 months)
Keystroke dynamics
Keypad time-related data and metadata collected unobtrusively from smartphone of patient
Time frame: Continuous throughout 12 months
Screen time
Screen time (hours) metrics collected unobtrusively from smartphone of patient
Time frame: Continuous throughout 12 months
Accelerometer data
Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Gyroscope sensor data
Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient
Time frame: Continuous throughout 12 months
Steps count
Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Physical activity intensity and categories
Physical activity intensity and physical activity categories collected unobtrusively from the smartwatch of patient to measure physical activity. Intensity and categories are features provided by the smartwatch. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Motion
Motion intensity collected unobtrusively smartwatch of patient to measure physical activity. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Distance
Distance (km) collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Pulse Ox
Pulse Ox collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Respiration
Respiration rate collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Body battery
Body battery collected unobtrusively from smartwatch of patient to measure stress on a scale. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Stress (digital)
Stress levels collected unobtrusively from smartwatch of patient to measure stress on a scale. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Heart rate
Heart rate collected unobtrusively from smartwatch of patient to measure stress
Time frame: Continuous throughout 12 months
Beat-to-beat intervals
Beat-to-beat intervals collected unobtrusively from smartwatch of patient to measure stress
Time frame: Continuous throughout 12 months
Sleeping time
Sleeping time (hours) collected unobtrusively from smartwatch of patient
Time frame: Continuous throughout 12 months
Sleeping type
Sleeping type (%) collected unobtrusively from smartwatch of patient
Time frame: Continuous throughout 12 months
Hand and feet photos
Images of hands and feet of the patient captured by the smartphone camera of the patient, to produce a feature vector relative to the condition of nails and joints of hands and toes resulting in an imaging digital biomarker
Time frame: 12 months (follow-up every 6 weeks and in case of flare)
Hand and body movements videos
Videos of pre-specified movements of hand and body recorded by the smartphone camera of the patient, to produce a set of time series with landmark coordinates (obtained from the videos) resulting in an imaging digital biomarker
Time frame: 12 months (follow-up every 6 weeks and in case of flare)
Medical history
* Age (years) * Sex * Years of disease (years) * Medication over the year of the study * Comorbidity * Care activities * Job title, shift work * Frequent flying (days)
Time frame: 12 months (follow-up every 3 months)
Joint count
66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints.
Time frame: 12 months (follow-up every 3 months)
Enthesitis
6 tendon count for enthesitis using Leeds Enthesitis Index
Time frame: 12 months (follow-up every 3 months)
Body surface area
Body Surface Area for skin
Time frame: 12 months (follow-up every 3 months)
Weight
Weight (kg) to calculate body mass index (BMI)
Time frame: Baseline
Height
Height (cm) to calculate BMI
Time frame: Baseline
Abdominal circumference
Abdominal circumference (cm)
Time frame: Baseline
ClASsification criteria for Psoriatic ARthritis (CASPAR) score
CASPAR score calculation for the classification of PsA using points from the following criteria: (i) evidence of current psoriasis, or personal or family history of psoriasis, (ii) dactylitis, (iii) juxtaarticular new bone formation, (iv) nail dystrophy, and (v) negative for rheumatoid factor.
Time frame: Baseline
Demographics
Questionnaire to assess demographics
Time frame: 12 months (follow-up every 3 months)
VAS Pain
VAS for pain assessment. Higher score indicate higher pain levels.
Time frame: 12 months (follow-up every 3 months)
HAQ questionnaire
HAQ questionnaire to measure physical function
Time frame: 12 months (follow-up every 3 months)
VAS patient global
VAS for patient global assessment
Time frame: 12 months (follow-up every 3 months)
PSAID questionnaire
PSAID questionnaire to measure impact of disease. Higher score indicates higher impact of disease.
Time frame: 12 months (follow-up every 3 months)
SF-36 questionnaire
SF-36 questionnaire for general health assessment
Time frame: 12 months (follow-up every 3 months)
EQ5d questionnaire
EQ5d questionnaire for general health assessment
Time frame: 12 months (follow-up every 3 months)
Work Productivity and Activity Impairment (WPAI) questionnaire
WPAI questionnaire for work impairment
Time frame: 12 months (follow-up every 3 months)
Health care questionnaire
Health care questionnaire for health care usage
Time frame: 12 months (follow-up every 3 months)
Patient Health Questionnaire (PHQ9) questionnaire
(PHQ9) questionnaire for depression assessment
Time frame: 12 months (follow-up every 3 months)
Perceived Stress Scale (PSS)
PSS questionnaire for stress
Time frame: 12 months (follow-up every 3 months)
Global Rating of Change (GRoC) Scale
GRoC scale to evaluate change in disease activity.
Time frame: 12 months (follow-up every 3 months)
Life events questionnaire
Life events questionnaire for life events
Time frame: 12 months (Baseline and month 12)
Digital literacy questionnaire
Digital literacy questionnaire for technology readiness
Time frame: Baseline
Inflammatory blood marker
Blood C-reactive protein levels (ml/L)
Time frame: 12 months (follow-up every 3 months)
Genetic variants
Salivary DNA analysis
Time frame: Baseline
Gut microbiome
Stool analysis to extract bacterial DNA using 16S sequencing
Time frame: 12 months (Baseline, in case of flare, and months 6 and 12 in subgroup of patients)
Stress (cortisol levels)
Hair cortisol analysis to measure stress
Time frame: 12 months (follow-up every 3 months)
No study locations are listed for this record.
Start is estimated for May 2024; primary completion for Dec 2025, 19 months later.
Of 75 non-industry observational studies under Arthritis, Psoriatic, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 20. This study's planned 19 months is below that.
Counting every sponsor, half of 127 studies reached it within 47 months; a quarter within 28 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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