- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07772544
Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study (PPIDC)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ana Maria Rodrigues, MD, PhD
- Telefonnummer: +351 965555061
- E-post: ana.m.rodrigues@nms.ul.pt
Studera Kontakt Backup
- Namn: Cátia Gonçalves, PhD
- E-post: catia.goncalves@nms.unl.pt
Studieorter
-
-
-
Thessaloniki, Grekland
- Hipokrateion Hospital Thessaloniki
-
Kontakt:
- Ioanna Katsigianni, MD
- Telefonnummer: +30 231 089 2000
- E-post: katsigianniioan@gmail.com
-
-
-
-
-
Aveiro, Portugal
- Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
-
Kontakt:
- Anabela Barcelos, MD, PhD
- Telefonnummer: +351 966894176
- E-post: barcelos.anabela@gmail.com
-
Lisbon, Portugal
- Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
-
Kontakt:
- Ana Teresa Melo, MD
- Telefonnummer: +351 918613549
- E-post: anateresamelo1992@gmail.com
-
Porto, Portugal
- Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
-
Kontakt:
- Alexandra Bernardo, MD
- Telefonnummer: +351 938507343
- E-post: alexbernardo@sapo.pt
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
System Usability Scale (SUS)
Tidsram: 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)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gyroskopsensordata
Tidsram: Kontinuerlig under 12 månader
|
Gyroskopsensordata för orientering insamlad diskret från patientens smartphone
|
Kontinuerlig under 12 månader
|
|
Fysisk aktivitetsintensitet och kategorier
Tidsram: Kontinuerlig under 12 månader
|
Fysisk aktivitetsintensitet och fysisk aktivitetskategorier insamlade diskret från patientens smartklocka för att mäta fysisk aktivitet.
Intensitet och kategorier är funktioner som tillhandahålls av smartklockan.
Patienterna kommer att bära smartklockan dagligen
|
Kontinuerlig under 12 månader
|
|
Stress (digital)
Tidsram: Kontinuerlig under 12 månader
|
Stressnivåer insamlade diskret från smartwatch av patienten för att mäta stress på en skala.
Detta är en funktion som tillhandahålls av smartwatch.
Patienterna kommer att bära smartklockan dagligen
|
Kontinuerlig under 12 månader
|
|
Sov dags
Tidsram: Kontinuerlig under 12 månader
|
Sovtid (timmar) samlas diskret från patientens smartklocka
|
Kontinuerlig under 12 månader
|
|
Sov typ
Tidsram: Kontinuerlig under 12 månader
|
Sovtyp (%) insamlad diskret från patientens smartklocka
|
Kontinuerlig under 12 månader
|
|
Foton på händer och fötter
Tidsram: 12 månader (uppföljning var 6:e vecka och vid blossning)
|
Bilder av händer och fötter på patienten tagna av patientens smartphonekamera, för att producera en funktionsvektor i förhållande till tillståndet hos naglar och leder i händer och tår, vilket resulterar i en digital biomarkör avbildande
|
12 månader (uppföljning var 6:e vecka och vid blossning)
|
|
Videor om hand- och kroppsrörelser
Tidsram: 12 månader (uppföljning var 6:e vecka och vid blossning)
|
Videor av fördefinierade hand- och kroppsrörelser inspelade av patientens smartphonekamera, för att producera en uppsättning tidsserier med landmärkeskoordinater (erhållna från videorna) som resulterar i en digital biomarkör för avbildning
|
12 månader (uppföljning var 6:e vecka och vid blossning)
|
|
Acceptability
Tidsram: Baseline
|
Number of eligible participants who agree to participate in the study.
|
Baseline
|
|
Perceptions of acceptability, barriers, facilitators, and experiences (patients)
Tidsram: T11 (Month 12)
|
Semi-structured focus group interviews
|
T11 (Month 12)
|
|
Step counts
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frågeformulär för digital läskunnighet
Tidsram: Baslinje
|
Digital läskunnighet frågeformulär för teknikberedskap
|
Baslinje
|
|
Genetic variants
Tidsram: T0 (1-Month)
|
Salivary DNA analysis
|
T0 (1-Month)
|
|
Gut microbiome
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
|
Waist circumference, measured in centimeters.
|
Baseline
|
|
Clinical and Disease History Characteristics
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, and T11 (Month 12)
|
Life events questionnaire for life events
|
Baseline, and T11 (Month 12)
|
|
Morning stiffness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Ana Maria Rodrigues, MD, PhD, NOVA Medical School
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 014/2026/CENMS
- 101095697 (Annat bidrag/finansieringsnummer: European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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