Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study (PPIDC)
15. september 2026 opdateret af: 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.
Studieoversigt
Status
Status
Ikke rekrutterer endnu
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
72
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Ana Maria Rodrigues, MD, PhD
- Telefonnummer: +351 965555061
- E-mail: ana.m.rodrigues@nms.ul.pt
Undersøgelse Kontakt Backup
- Navn: Cátia Gonçalves, PhD
- E-mail: catia.goncalves@nms.unl.pt
Studiesteder
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Thessaloniki, Grækenland
- Hipokrateion Hospital Thessaloniki
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Kontakt:
- Ioanna Katsigianni, MD
- Telefonnummer: +30 231 089 2000
- E-mail: katsigianniioan@gmail.com
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Aveiro, Portugal
- Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
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Kontakt:
- Anabela Barcelos, MD, PhD
- Telefonnummer: +351 966894176
- E-mail: barcelos.anabela@gmail.com
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Lisbon, Portugal
- Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
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Kontakt:
- Ana Teresa Melo, MD
- Telefonnummer: +351 918613549
- E-mail: anateresamelo1992@gmail.com
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Porto, Portugal
- Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
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Kontakt:
- Alexandra Bernardo, MD
- Telefonnummer: +351 938507343
- E-mail: alexbernardo@sapo.pt
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
1
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: 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.
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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. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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System Usability Scale (SUS)
Tidsramme: T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
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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.
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T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
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eHealth UsaBility Benchmarking instrument (HUBBI)
Tidsramme: T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
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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).
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T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gyroskopsensordata
Tidsramme: Kontinuerlig i 12 måneder
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Gyroskopsensordata til orientering indsamlet diskret fra patientens smartphone
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Kontinuerlig i 12 måneder
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Fysisk aktivitetsintensitet og kategorier
Tidsramme: Kontinuerlig i 12 måneder
|
Fysisk aktivitetsintensitet og fysisk aktivitetskategorier indsamlet diskret fra patientens smartwatch for at måle fysisk aktivitet.
Intensitet og kategorier er funktioner leveret af smartwatch.
Patienter vil bære smartwatchet dagligt
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Kontinuerlig i 12 måneder
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Stress (digital)
Tidsramme: Kontinuerlig i 12 måneder
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Stressniveauer indsamlet diskret fra patientens smartwatch for at måle stress på en skala.
Dette er en funktion leveret af smartwatchet.
Patienter vil bære smartwatchet dagligt
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Kontinuerlig i 12 måneder
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Sengetid
Tidsramme: Kontinuerlig i 12 måneder
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Sovetid (timer) indsamlet diskret fra patientens smartwatch
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Kontinuerlig i 12 måneder
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Sovende type
Tidsramme: Kontinuerlig i 12 måneder
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Sovende type (%) indsamlet diskret fra patientens smartwatch
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Kontinuerlig i 12 måneder
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Hånd og fødder fotos
Tidsramme: 12 måneder (opfølgning hver 6. uge og i tilfælde af opblussen)
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Billeder af patientens hænder og fødder optaget af patientens smartphone-kamera for at producere en funktionsvektor i forhold til tilstanden af negle og led i hænder og tæer, hvilket resulterer i en billeddannende digital biomarkør
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12 måneder (opfølgning hver 6. uge og i tilfælde af opblussen)
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Hånd- og kropsbevægelser videoer
Tidsramme: 12 måneder (opfølgning hver 6. uge og i tilfælde af opblussen)
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Videoer af forudspecificerede bevægelser af hånd og krop optaget af patientens smartphone-kamera for at producere et sæt tidsserier med skelsættende koordinater (opnået fra videoerne), hvilket resulterer i en billeddannende digital biomarkør
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12 måneder (opfølgning hver 6. uge og i tilfælde af opblussen)
|
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Acceptability
Tidsramme: Baseline
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Number of eligible participants who agree to participate in the study.
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Baseline
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Perceptions of acceptability, barriers, facilitators, and experiences (patients)
Tidsramme: T11 (Month 12)
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Semi-structured focus group interviews
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T11 (Month 12)
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Step counts
Tidsramme: Continuous, throughout 12 months
|
Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity.
Patients will wear the smartwatch daily
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Continuous, throughout 12 months
|
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Accelerometer data
Tidsramme: Continuous, throughout 12 months
|
Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity.
Patients will wear the smartwatch daily
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Continuous, throughout 12 months
|
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Number of Flares Reported via the miPROLEPSIS Application
Tidsramme: Continuous throughout 12 months
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Number of disease flares self-reported by patients directly through the miPROLEPSIS application.
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Continuous throughout 12 months
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Number of Flares Reported via Patient and Rheumatologist
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
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Count of disease flares reported using the structured Patient and Rheumatologist flare questionnaires developed in the iPROLEPSIS-PDPID study, completed during clinical visits.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
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Body Mass Index (BMI)
Tidsramme: Baseline
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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).
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Baseline
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Minimal Disease Activity (MDA) status
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Minimal Disease Activity status based on predefined criteria, determined from joint counts, pain, global activity, and function.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Psoriatic Arthritis Disease Activity Score (PASDAS)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Disease Activity in Psoriatic Arthritis (DAPSA) Score
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Psoriatic Arthritis Impact of Disease (PsAID)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Validated patient-reported measure assessing disease impact across domains such as pain, fatigue, work, and emotional well-being
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Arthritis Self-Efficacy Scale (ASES)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Perceived Stress Scale (PSS)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Short Form-36 Health Survey (SF-36)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Tidsramme: T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Self-reported physical activity levels across intensity domains (walking, moderate, vigorous), duration, and frequency over the past 7 days
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T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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14-item Mediterranean Diet Adherence Screener (14-MEDAS)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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)
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EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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).
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Work Productivity and Activity Impairment (WPAI)
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
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Healthcare utilisation
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Self-reported use of healthcare services, including visits to GPs and specialists.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Safety assessment
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
|
Number of adverse events (AEs) and serious adverse events (SAEs).
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Heart rate
Tidsramme: Continuous throughout 12 months
|
Heart rate collected unobtrusively from smartwatch of patient.
Patients will wear the smartwatch daily
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Continuous throughout 12 months
|
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Heart rate variability
Tidsramme: 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.
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Continuous throughout 12 months
|
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Keystroke Dynamics
Tidsramme: 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.
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Continuous throughout 12 months
|
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Session Frequency (iPROLEPSIS apps)
Tidsramme: 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
|
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Session Duration (iPROLEPSIS apps)
Tidsramme: Continuous, throughout 11 months
|
Dwell time within each application, i.e., duration of each user session, in minutes.
|
Continuous, throughout 11 months
|
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Feature Access Rate (iPROLEPSIS Apps)
Tidsramme: 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
|
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Task Completion Rate (iPROLEPSIS Apps)
Tidsramme: Continuous throughout 12 months
|
Ratio of the number of completed tasks to the number of abandoned or incomplete tasks
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Continuous throughout 12 months
|
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Notification Action Rate (iPROLEPSIS Apps)
Tidsramme: Continuous throughout 12 months
|
Ratio of the number of opened notifications to the number of resulting task completions
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Continuous throughout 12 months
|
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Time on Task (iPROLEPSIS Apps)
Tidsramme: Continuous throughout 12 months
|
Time taken by users to complete a defined in-app task, in minutes.
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Continuous throughout 12 months
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Error Rate (iPROLEPSIS Apps)
Tidsramme: 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).
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Continuous throughout 12 months
|
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User-Generated Data Entries (iPROLEPSIS Apps)
Tidsramme: Continuous throughout 12 months
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Frequency and quantity of user-initiated data input, indicating active engagement and perceived app utility
|
Continuous throughout 12 months
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Number of Dashboard Sessions Logged (HCP Dashboard)
Tidsramme: Continuous throughout 12 months
|
Number of times healthcare professionals log into the iPROLEPSIS clinical dashboard
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Continuous throughout 12 months
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Incremental Cost of Implementing the iPROLEPSIS Digital Health Programme Compared with Standard Care
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spørgeskema om digitale færdigheder
Tidsramme: Baseline
|
Spørgeskema til digitale færdigheder til teknologisk parathed
|
Baseline
|
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Genetic variants
Tidsramme: T0 (1-Month)
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Salivary DNA analysis
|
T0 (1-Month)
|
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Gut microbiome
Tidsramme: T0 (1-Month) and T3 (4-Month)
|
Stool analysis to extract bacterial DNA using 16S sequencing
|
T0 (1-Month) and T3 (4-Month)
|
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Inflammatory blood marker
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Blood C-reactive protein levels (ml/L)
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
|
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Waist Circumference
Tidsramme: Baseline
|
Waist circumference, measured in centimeters.
|
Baseline
|
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Clinical and Disease History Characteristics
Tidsramme: 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
|
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Demographics
Tidsramme: 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.
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Baseline
|
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Global Rating of Change (GRoC) Scale
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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GRoC scale to evaluate change in disease activity.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Life events questionnaire
Tidsramme: Baseline, and T11 (Month 12)
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Life events questionnaire for life events
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Baseline, and T11 (Month 12)
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Morning stiffness
Tidsramme: 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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Air travel events
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Air travel during the study period, including the occurrence, number, dates and purpose (vacation or work), as reported by participants.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Supplement use
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Use of dietary supplements, including supplement type, dose, frequency, and duration of use, as reported by participants.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Joint count
Tidsramme: 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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Enthesitis
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
|
6 tendon count for enthesitis using Leeds Enthesitis Index
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Psoriasis Area and Severity Index (PASI)
Tidsramme: 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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Dactylitis Severity Score (DSS)
Tidsramme: 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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Life Satisfaction
Tidsramme: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
|
Self-reported life satisfaction (0-10).
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Ana Maria Rodrigues, MD, PhD, NOVA Medical School
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
Studiestart
1. september 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. december 2027
Studieafslutning (Anslået)
Studieafslutning
1. december 2027
Datoer for studieregistrering
Først indsendt
Først indsendt
8. august 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
13. august 2026
Først opslået (Faktiske)
Først opslået
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 014/2026/CENMS
- 101095697 (Andet bevillings-/finansieringsnummer: European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))
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