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Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study (PPIDC)

15 september 2026 bijgewerkt door: Sociedade Portuguesa de Reumatologia

iPROLEPSIS-PPIDC: Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study

This is an international, multicentre, feasibility mixed-methods, single-arm study evaluating the implementation of the iPROLEPSIS digital health promotion programme for adults with psoriatic arthritis (PsA) in real-world clinical practice.

The study will enrol 72 adults with PsA (18 participants per country) across Portugal, the Netherlands, Greece, and the United Kingdom. Participants will be followed for 12 months, including a 1-month baseline monitoring period without intervention, followed by an 11-month intervention period during which participants will use the iPROLEPSIS digital health ecosystem. The iPROLEPSIS ecosystem integrates multiple digital health tools designed to support lifestyle management, self-monitoring, and patient engagement in PsA care. Participants will use the miPROLEPSIS app for active and passive data collection and personalised lifestyle recommendations related to diet and physical activity; biAURA for sleep and stress management using binaural beats; iPROLEPSIS Games to promote physical and emotional well-beingthrough serious games; and the miPROLEPSIS Joint Landmarker app for video-based functional assessments. The ecosystem will also integrate data from a Garmin vívoactive 5 smartwatch and wireless earbuds. Healthcare professionals involved in participant follow-up will access a dedicated clinical dashboard to support monitoring and clinical management. The primary objective of this feasibility study is to evaluate the usability of the iPROLEPSIS digital health ecosystem among patients with PsA and healthcare professionals using the System Usability Scale (SUS) and the eHealth UsaBility Benchmarking Instrument (HUBBI). Secondary objectives include assessing participant retention, acceptability of study participation, engagement with the digital health tools, adherence to study procedures, and identifying barriers and facilitators influencing the implementation of the digital health programme in routine clinical practice.The study will also generate preliminary evidence regarding potential changes in clinical and patient-reported outcomes associated with the use of the iPROLEPSIS ecosystem and include a preliminary budget impact analysis to inform the design of a future larger-scale clinical trial.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Griekenland
      • Thessaloniki, Griekenland
        • Hipokrateion Hospital Thessaloniki
        • Contact:
  • Portugal
      • Aveiro, Portugal
        • Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
        • Contact:
      • Lisbon, Portugal
        • Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
        • Contact:
      • Porto, Portugal
        • Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria (Patients):

  • Willing and able to provide informed consent
  • Female or male, aged 18 years or older at the time of enrolment
  • Diagnosed with psoriatic arthritis
  • Had a rheumatology appointment in the past 12 months
  • Owns a smartphone (Android) compatible with the study apps
  • Willing to use the study smartwatch (Garmin Vivoactive 5) for the 12-month follow-up period
  • Proficient in the local language

Inclusion Criteria (Healthcare Professionals):

  • Willing and able to provide informed consent
  • Involved in the clinical follow-up of PsA patients enrolled in the study

Exclusion Criteria (Patients):

  • Illiteracy or inability to comply with the study protocol (e.g., due to hearing or visual impairments or significant cognitive impairment)
  • Lack of access to the necessary technology to participate in the study (e.g., smartphone or stable internet connection)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: iPROLEPSIS Digital Health Ecossystem
Participants with psoriatic arthritis will undergo a 12-month study period consisting of a 1-month baseline monitoring phase followed by an 11-month intervention phase. During the intervention period, participants will receive the iPROLEPSIS digital health programme , integrated with a wearable smartwatch and wireless earbuds. Healthcare professionals involved in participant follow up will use a dedicated clinical dashboard.
Gedragsmatig: iPROLEPSIS Digital Health Ecossystem

The iPROLEPSIS Digital Health Programme is a multimodal digital health intervention designed to support self-management, healthy lifestyle behaviours, and remote clinical follow-up in adults with psoriatic arthritis. Participants will use the miPROLEPSIS mobile application for symptom monitoring, passive and active data collection, and personalised lifestyle recommendations; biAURA for sleep and stress management; iPROLEPSIS Games to promote physical and emotional well-being; and the miPROLEPSIS Joint Landmarker application for video-based functional assessment. The ecossystem also integrates a smartwatch and wireless earbuds.

Healthcare professionals will use a dedicated clinical dashboard to monitor participant data and support clinical management throughout the intervention period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
System Usability Scale (SUS)
Tijdsspanne: T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
A validated 10-item questionnaire assessing ease of system use, scored on a 5-point Likert scale and converted to a 0-100 scale. A score ≥68 indicates above-average usability.
T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
eHealth UsaBility Benchmarking instrument (HUBBI)
Tijdsspanne: T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
A structured heuristic tool assessing usability across seven domains (Basic System Performance, Task-Technology Fit, Interface Design, Navigation & Structure, Information & Terminology, Guidance & Support, Satisfaction). Results are presented as categorical ratings (Good, Moderate, Insufficient, Poor).
T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gegevens van de gyroscoopsensor
Tijdsspanne: Continu gedurende 12 maanden
Gyroscoopsensorgegevens voor oriëntatie verzameld onopvallend vanaf de smartphone van de patiënt
Continu gedurende 12 maanden
Intensiteit en categorieën van fysieke activiteit
Tijdsspanne: Continu gedurende 12 maanden
Lichamelijke activiteitsintensiteit en fysieke activiteitscategorieën worden onopvallend verzameld van de smartwatch van de patiënt om de fysieke activiteit te meten. Intensiteit en categorieën zijn functies van de smartwatch. Patiënten zullen de smartwatch dagelijks dragen
Continu gedurende 12 maanden
Stress (digitaal)
Tijdsspanne: Continu gedurende 12 maanden
Stressniveaus worden onopvallend verzameld via de smartwatch van de patiënt om stress op schaal te meten. Dit is een functie van de smartwatch. Patiënten zullen de smartwatch dagelijks dragen
Continu gedurende 12 maanden
Bedtijd
Tijdsspanne: Continu gedurende 12 maanden
Slaaptijd (uren) onopvallend verzameld via smartwatch van patiënt
Continu gedurende 12 maanden
Slaaptype
Tijdsspanne: Continu gedurende 12 maanden
Slaaptype (%) onopvallend verzameld via smartwatch van patiënt
Continu gedurende 12 maanden
Foto's van handen en voeten
Tijdsspanne: 12 maanden (follow-up elke 6 weken en bij opflakkering)
Afbeeldingen van handen en voeten van de patiënt, vastgelegd door de smartphonecamera van de patiënt, om een ​​kenmerkvector te produceren met betrekking tot de toestand van nagels en gewrichten van handen en tenen, resulterend in een beeldvormende digitale biomarker
12 maanden (follow-up elke 6 weken en bij opflakkering)
Video's over hand- en lichaamsbewegingen
Tijdsspanne: 12 maanden (follow-up elke 6 weken en bij opflakkering)
Video's van vooraf gespecificeerde bewegingen van hand en lichaam, opgenomen door de smartphonecamera van de patiënt, om een ​​reeks tijdreeksen te produceren met oriëntatiepuntcoördinaten (verkregen uit de video's), resulterend in een beeldvormende digitale biomarker
12 maanden (follow-up elke 6 weken en bij opflakkering)
Acceptability
Tijdsspanne: Baseline
Number of eligible participants who agree to participate in the study.
Baseline
Perceptions of acceptability, barriers, facilitators, and experiences (patients)
Tijdsspanne: T11 (Month 12)
Semi-structured focus group interviews
T11 (Month 12)
Step counts
Tijdsspanne: Continuous, throughout 12 months
Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Continuous, throughout 12 months
Accelerometer data
Tijdsspanne: Continuous, throughout 12 months
Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity. Patients will wear the smartwatch daily
Continuous, throughout 12 months
Number of Flares Reported via the miPROLEPSIS Application
Tijdsspanne: Continuous throughout 12 months
Number of disease flares self-reported by patients directly through the miPROLEPSIS application.
Continuous throughout 12 months
Number of Flares Reported via Patient and Rheumatologist
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
Count of disease flares reported using the structured Patient and Rheumatologist flare questionnaires developed in the iPROLEPSIS-PDPID study, completed during clinical visits.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
Body Mass Index (BMI)
Tijdsspanne: Baseline
Calculated as weight in kilograms divided by the square of height in meters (kg/m²). Used to classify nutritional status (underweight, normal weight, overweight, obesity).
Baseline
Minimal Disease Activity (MDA) status
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Minimal Disease Activity status based on predefined criteria, determined from joint counts, pain, global activity, and function.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Psoriatic Arthritis Disease Activity Score (PASDAS)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Composite disease activity score combining clinical and patient-reported variables. Total score ranges from 0 to 10; higher scores indicate more active disease. Low disease activity is defined as a score <3.2.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Disease Activity in Psoriatic Arthritis (DAPSA) Score
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Composite score derived from tender joint count (0-68), swollen joint count (0-66), C-reactive protein level (mg/dL), patient pain (0-10 cm VAS), and patient global assessment (0-10). Higher scores indicate more active disease.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Psoriatic Arthritis Impact of Disease (PsAID)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Validated patient-reported measure assessing disease impact across domains such as pain, fatigue, work, and emotional well-being
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Arthritis Self-Efficacy Scale (ASES)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
8-item scale measuring perceived self-efficacy in managing pain and other arthritis-related symptoms. Scores range from 10 to 100, with higher scores indicating greater self-efficacy.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Patient Health Questionnaire-9 (PHQ-9)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
9-item instrument for screening and measuring the severity of depressive symptoms in the previous two weeks. Score ranges from 0 to 27. Higher scores indicate more severe depressive symptoms
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Perceived Stress Scale (PSS)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Self-reported questionnaire measuring the degree to which individuals perceive their life situations as stressful, over the past month. Scores are calculated by summing item responses, with higher scores indicating greater perceived stress.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Short Form-36 Health Survey (SF-36)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Standardised questionnaire assessing assessing health-related quality of live across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed to a 0-100 scale. Higher scores indicate better health status.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Tijdsspanne: T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Self-reported physical activity levels across intensity domains (walking, moderate, vigorous), duration, and frequency over the past 7 days
T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Health Assessment Questionnaire Disability Index (HAQ-DI)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
20-item scale assessing difficulties in performing daily activities. Responses range from 0 (no difficulty) to 3 (unable to do). Higher scores indicate worse functional disability.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
14-item Mediterranean Diet Adherence Screener (14-MEDAS)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Questionnaire assessing adherence to Mediterranean dietary pattern. Score ranges from 0 to 14; higher scores reflect greater adherence.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Standardised instrument measuring quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Includes an index score and visual analogue scale (VAS).
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Work Productivity and Activity Impairment (WPAI)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
Self-reported questionnaire measuring the degree to which health problems affect work productivity and regular activities. Includes absenteeism, presenteeism, and overall work and activity impairment.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
Healthcare utilisation
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Self-reported use of healthcare services, including visits to GPs and specialists.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Safety assessment
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Number of adverse events (AEs) and serious adverse events (SAEs).
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Heart rate
Tijdsspanne: Continuous throughout 12 months
Heart rate collected unobtrusively from smartwatch of patient. Patients will wear the smartwatch daily
Continuous throughout 12 months
Heart rate variability
Tijdsspanne: Continuous throughout 12 months
Heart rate variability (HRV) collected unobtrusively from the patient's smartwatch to assess variations in heart rate. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily.
Continuous throughout 12 months
Keystroke Dynamics
Tijdsspanne: Continuous throughout 12 months
Keypad time-related data (e.g., inter-key press intervals) and associated metadata, collected unobtrusively from the patient's smartphone during app use, for fine motor function.
Continuous throughout 12 months
Session Frequency (iPROLEPSIS apps)
Tijdsspanne: Continuous, through 12 months of follow-up
Number of discrete user sessions or app log-ins over the study period, indicating engagement consistency and sustained participation.
Continuous, through 12 months of follow-up
Session Duration (iPROLEPSIS apps)
Tijdsspanne: Continuous, throughout 11 months
Dwell time within each application, i.e., duration of each user session, in minutes.
Continuous, throughout 11 months
Feature Access Rate (iPROLEPSIS Apps)
Tijdsspanne: Continuous throughout 12 months
Number of times users access specific app features or modules, reflecting breadth and depth of feature engagement.
Continuous throughout 12 months
Task Completion Rate (iPROLEPSIS Apps)
Tijdsspanne: Continuous throughout 12 months
Ratio of the number of completed tasks to the number of abandoned or incomplete tasks
Continuous throughout 12 months
Notification Action Rate (iPROLEPSIS Apps)
Tijdsspanne: Continuous throughout 12 months
Ratio of the number of opened notifications to the number of resulting task completions
Continuous throughout 12 months
Time on Task (iPROLEPSIS Apps)
Tijdsspanne: Continuous throughout 12 months
Time taken by users to complete a defined in-app task, in minutes.
Continuous throughout 12 months
Error Rate (iPROLEPSIS Apps)
Tijdsspanne: Continuous throughout 12 months
Application) Ratio of the number of successful task attempts to the number of failed attempts (e.g., failed photo submissions or failed video tests).
Continuous throughout 12 months
User-Generated Data Entries (iPROLEPSIS Apps)
Tijdsspanne: Continuous throughout 12 months
Frequency and quantity of user-initiated data input, indicating active engagement and perceived app utility
Continuous throughout 12 months
Number of Dashboard Sessions Logged (HCP Dashboard)
Tijdsspanne: Continuous throughout 12 months
Number of times healthcare professionals log into the iPROLEPSIS clinical dashboard
Continuous throughout 12 months
Incremental Cost of Implementing the iPROLEPSIS Digital Health Programme Compared with Standard Care
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Estimated incremental cost (local currency) of implementing the iPROLEPSIS digital health tools vs. standard care, from a healthcare system perspective, including key cost drivers and sensitivity analyses.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Vragenlijst digitale geletterdheid
Tijdsspanne: Basislijn
Vragenlijst over digitale geletterdheid voor technologiegereedheid
Basislijn
Genetic variants
Tijdsspanne: T0 (1-Month)
Salivary DNA analysis
T0 (1-Month)
Gut microbiome
Tijdsspanne: T0 (1-Month) and T3 (4-Month)
Stool analysis to extract bacterial DNA using 16S sequencing
T0 (1-Month) and T3 (4-Month)
Inflammatory blood marker
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Blood C-reactive protein levels (ml/L)
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Waist Circumference
Tijdsspanne: Baseline
Waist circumference, measured in centimeters.
Baseline
Clinical and Disease History Characteristics
Tijdsspanne: Baseline
Descriptive clinical history collected at enrolment, including fulfilment of CASPAR classification criteria for psoriatic arthritis, psoriatic arthritis subtype, symptom onset date, diagnosis date, and comorbidities.
Baseline
Demographics
Tijdsspanne: Baseline
Descriptive characteristics collected at enrolment, including age, sex, nationality, ethnicity/race, marital status, household composition, education level, digital literacy, professional occupation/shift work, handedness and typing fingers used, birth history (mode of delivery: caesarean vs. vaginal), presence of family care/dependent responsibilities, dietary habits, alcohol consumption, and smoking status.
Baseline
Global Rating of Change (GRoC) Scale
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
GRoC scale to evaluate change in disease activity.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Life events questionnaire
Tijdsspanne: Baseline, and T11 (Month 12)
Life events questionnaire for life events
Baseline, and T11 (Month 12)
Morning stiffness
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Air travel events
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Air travel during the study period, including the occurrence, number, dates and purpose (vacation or work), as reported by participants.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Supplement use
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Use of dietary supplements, including supplement type, dose, frequency, and duration of use, as reported by participants.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Joint count
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Enthesitis
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
6 tendon count for enthesitis using Leeds Enthesitis Index
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Psoriasis Area and Severity Index (PASI)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Physician-assessed measure of psoriasis severity and extent across four body regions (head, trunk, upper limbs, lower limbs), combining erythema, induration, and desquamation with area affected. Score ranges from 0-72; higher scores indicate more severe/extensive disease.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Dactylitis Severity Score (DSS)
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Physician-assessed measure of dactylitis severity, scored per digit (fingers and toes) on a scale from 0 (no dactylitis) to 3 (most severe). The total score is the sum across all assessed digits, yielding a possible total range of 0 to 60; higher scores indicate more severe dactylitis.
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Life Satisfaction
Tijdsspanne: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Self-reported life satisfaction (0-10).
Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sociedade Portuguesa de Reumatologia

Medewerkers

Erasmus Medical Center
University of Oxford
Aristotle University Of Thessaloniki
NOVA Medical School

Onderzoekers

  • Hoofdonderzoeker: Ana Maria Rodrigues, MD, PhD, NOVA Medical School

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

8 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 augustus 2026

Eerst geplaatst (Werkelijk)

19 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 014/2026/CENMS
  • 101095697 (Ander subsidie-/financieringsnummer: European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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