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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06347237
Other study ID # NL84429.078.23
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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)
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