PsA Digital Phenotyping and Inflammation Drivers Study

Psoriatic Arthritis Clinical Trial

— PDPID  

Official title:

PsA Digital Phenotyping and Inflammation Drivers Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347237
• Other study ID #: NL84429.078.23
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Flare Up, Symptom
• Inflammation
• Psoriatic Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Keystroke dynamics	Keypad time-related data and metadata collected unobtrusively from smartphone of patient	Continuous throughout 12 months
Other	Screen time	Screen time (hours) metrics collected unobtrusively from smartphone of patient	Continuous throughout 12 months
Other	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
Other	Gyroscope sensor data	Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient	Continuous throughout 12 months
Other	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
Other	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
Other	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
Other	Distance	Distance (km) collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily	Continuous throughout 12 months
Other	Pulse Ox	Pulse Ox collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily	Continuous throughout 12 months
Other	Respiration	Respiration rate collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily	Continuous throughout 12 months
Other	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
Other	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
Other	Heart rate	Heart rate collected unobtrusively from smartwatch of patient to measure stress	Continuous throughout 12 months
Other	Beat-to-beat intervals	Beat-to-beat intervals collected unobtrusively from smartwatch of patient to measure stress	Continuous throughout 12 months
Other	Sleeping time	Sleeping time (hours) collected unobtrusively from smartwatch of patient	Continuous throughout 12 months
Other	Sleeping type	Sleeping type (%) collected unobtrusively from smartwatch of patient	Continuous throughout 12 months
Other	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)
Other	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)
Other	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)
Other	Joint count	66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints.	12 months (follow-up every 3 months)
Other	Enthesitis	6 tendon count for enthesitis using Leeds Enthesitis Index	12 months (follow-up every 3 months)
Other	Body surface area	Body Surface Area for skin	12 months (follow-up every 3 months)
Other	Weight	Weight (kg) to calculate body mass index (BMI)	Baseline
Other	Height	Height (cm) to calculate BMI	Baseline
Other	Abdominal circumference	Abdominal circumference (cm)	Baseline
Other	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
Other	Demographics	Questionnaire to assess demographics	12 months (follow-up every 3 months)
Other	VAS Pain	VAS for pain assessment. Higher score indicate higher pain levels.	12 months (follow-up every 3 months)
Other	HAQ questionnaire	HAQ questionnaire to measure physical function	12 months (follow-up every 3 months)
Other	VAS patient global	VAS for patient global assessment	12 months (follow-up every 3 months)
Other	PSAID questionnaire	PSAID questionnaire to measure impact of disease. Higher score indicates higher impact of disease.	12 months (follow-up every 3 months)
Other	SF-36 questionnaire	SF-36 questionnaire for general health assessment	12 months (follow-up every 3 months)
Other	EQ5d questionnaire	EQ5d questionnaire for general health assessment	12 months (follow-up every 3 months)
Other	Work Productivity and Activity Impairment (WPAI) questionnaire	WPAI questionnaire for work impairment	12 months (follow-up every 3 months)
Other	Health care questionnaire	Health care questionnaire for health care usage	12 months (follow-up every 3 months)
Other	Patient Health Questionnaire (PHQ9) questionnaire	(PHQ9) questionnaire for depression assessment	12 months (follow-up every 3 months)
Other	Perceived Stress Scale (PSS)	PSS questionnaire for stress	12 months (follow-up every 3 months)
Other	Global Rating of Change (GRoC) Scale	GRoC scale to evaluate change in disease activity.	12 months (follow-up every 3 months)
Other	Life events questionnaire	Life events questionnaire for life events	12 months (Baseline and month 12)
Other	Digital literacy questionnaire	Digital literacy questionnaire for technology readiness	Baseline
Other	Inflammatory blood marker	Blood C-reactive protein levels (ml/L)	12 months (follow-up every 3 months)
Other	Genetic variants	Salivary DNA analysis	Baseline
Other	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)
Other	Stress (cortisol levels)	Hair cortisol analysis to measure stress	12 months (follow-up every 3 months)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Morning stiffness	Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.	12 months (follow-up every 3 months)

External Links

•   iPROLEPSIS project website