PsA Digital Phenotyping and Inflammation Drivers Study (PDPID)

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:

• In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?
• In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?

Participants will be requested to:

• Install app on their phone
• Use a smartwatch
• Complete questionnaires
• Collect biological material

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriatic Arthritis; Flare Up, Symptom; Psoriatic Arthritis Aggravated

• Study Type: Observational
• Enrollment (Estimated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with psoriatic arthritis

Description

Inclusion Criteria:

• Diagnosed with PsA
• Age 18 years or older and competent
• Using a smartphone
• Agree to use smartwatch
• Good command of the local language

Exclusion Criteria:

• Less than 18 years of age
• Incapacitated

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months (follow-up every 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	12 months (follow-up every 3 months)
Morning stiffness	Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.	12 months (follow-up every 3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keystroke dynamics	Keypad time-related data and metadata collected unobtrusively from smartphone of patient	Continuous throughout 12 months
Screen time	Screen time (hours) metrics collected unobtrusively from smartphone of patient	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	Continuous throughout 12 months
Gyroscope sensor data	Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient	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	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	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	Continuous throughout 12 months
Distance	Distance (km) collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily	Continuous throughout 12 months
Pulse Ox	Pulse Ox collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily	Continuous throughout 12 months
Respiration	Respiration rate collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily	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	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	Continuous throughout 12 months
Heart rate	Heart rate collected unobtrusively from smartwatch of patient to measure stress	Continuous throughout 12 months
Beat-to-beat intervals	Beat-to-beat intervals collected unobtrusively from smartwatch of patient to measure stress	Continuous throughout 12 months
Sleeping time	Sleeping time (hours) collected unobtrusively from smartwatch of patient	Continuous throughout 12 months
Sleeping type	Sleeping type (%) collected unobtrusively from smartwatch of patient	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	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	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)	12 months (follow-up every 3 months)
Joint count	66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints.	12 months (follow-up every 3 months)
Enthesitis	6 tendon count for enthesitis using Leeds Enthesitis Index	12 months (follow-up every 3 months)
Body surface area	Body Surface Area for skin	12 months (follow-up every 3 months)
Weight	Weight (kg) to calculate body mass index (BMI)	Baseline
Height	Height (cm) to calculate BMI	Baseline
Abdominal circumference	Abdominal circumference (cm)	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.	Baseline
Demographics	Questionnaire to assess demographics	12 months (follow-up every 3 months)
VAS Pain	VAS for pain assessment. Higher score indicate higher pain levels.	12 months (follow-up every 3 months)
HAQ questionnaire	HAQ questionnaire to measure physical function	12 months (follow-up every 3 months)
VAS patient global	VAS for patient global assessment	12 months (follow-up every 3 months)
PSAID questionnaire	PSAID questionnaire to measure impact of disease. Higher score indicates higher impact of disease.	12 months (follow-up every 3 months)
SF-36 questionnaire	SF-36 questionnaire for general health assessment	12 months (follow-up every 3 months)
EQ5d questionnaire	EQ5d questionnaire for general health assessment	12 months (follow-up every 3 months)
Work Productivity and Activity Impairment (WPAI) questionnaire	WPAI questionnaire for work impairment	12 months (follow-up every 3 months)
Health care questionnaire	Health care questionnaire for health care usage	12 months (follow-up every 3 months)
Patient Health Questionnaire (PHQ9) questionnaire	(PHQ9) questionnaire for depression assessment	12 months (follow-up every 3 months)
Perceived Stress Scale (PSS)	PSS questionnaire for stress	12 months (follow-up every 3 months)
Global Rating of Change (GRoC) Scale	GRoC scale to evaluate change in disease activity.	12 months (follow-up every 3 months)
Life events questionnaire	Life events questionnaire for life events	12 months (Baseline and month 12)
Digital literacy questionnaire	Digital literacy questionnaire for technology readiness	Baseline
Inflammatory blood marker	Blood C-reactive protein levels (ml/L)	12 months (follow-up every 3 months)
Genetic variants	Salivary DNA analysis	Baseline
Gut microbiome	Stool analysis to extract bacterial DNA using 16S sequencing	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	12 months (follow-up every 3 months)

Collaborators and Investigators

• Sponsor: Jolanda Luime
• Collaborators: University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences; Aristotle University of Thessaloniki - Hipokrateion Hospital Thessaloniki; Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt)

Publications and helpful links

Helpful Links

• iPROLEPSIS project website

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: inflammation; psoriatic arthritis; flare; digital biomarker
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Recurrence; Arthritis; Inflammation; Arthritis, Psoriatic; Symptom Flare Up
• Other Study ID Numbers: NL84429.078.23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No