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

15 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

72

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Ana Maria Rodrigues, MD, PhD
  • Номер телефона: +351 965555061
  • Электронная почта: ana.m.rodrigues@nms.ul.pt

Учебное резервное копирование контактов

Места учебы

  • Греция
      • Thessaloniki, Греция
        • Hipokrateion Hospital Thessaloniki
        • Контакт:
          • Ioanna Katsigianni, MD
          • Номер телефона: +30 231 089 2000
          • Электронная почта: katsigianniioan@gmail.com
  • Португалия
      • Aveiro, Португалия
        • Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
        • Контакт:
          • Anabela Barcelos, MD, PhD
          • Номер телефона: +351 966894176
          • Электронная почта: barcelos.anabela@gmail.com
      • Lisbon, Португалия
        • Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
        • Контакт:
      • Porto, Португалия
        • Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
        • Контакт:
          • Alexandra Bernardo, MD
          • Номер телефона: +351 938507343
          • Электронная почта: alexbernardo@sapo.pt

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
System Usability Scale (SUS)
Временное ограничение: 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)
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Данные датчика гироскопа
Временное ограничение: Непрерывно в течение 12 месяцев
Данные датчика гироскопа для ориентации незаметно собираются со смартфона пациента.
Непрерывно в течение 12 месяцев
Интенсивность и категории физической активности
Временное ограничение: Непрерывно в течение 12 месяцев
Интенсивность физической активности и категории физической активности незаметно собираются с умных часов пациента для измерения физической активности. Интенсивность и категории — это функции, предоставляемые умными часами. Пациенты будут носить умные часы ежедневно
Непрерывно в течение 12 месяцев
Стресс (цифровой)
Временное ограничение: Непрерывно в течение 12 месяцев
Уровни стресса незаметно собираются с умных часов пациента для измерения стресса по шкале. Это функция умных часов. Пациенты будут носить умные часы ежедневно
Непрерывно в течение 12 месяцев
Время сна
Временное ограничение: Непрерывно в течение 12 месяцев
Время сна (часы), незаметно собираемое с умных часов пациента.
Непрерывно в течение 12 месяцев
Тип сна
Временное ограничение: Непрерывно в течение 12 месяцев
Тип сна (%), незаметно собранный с умных часов пациента
Непрерывно в течение 12 месяцев
Фото рук и ног
Временное ограничение: 12 месяцев (наблюдение каждые 6 недель и в случае обострения)
Изображения рук и ног пациента, снятые камерой смартфона пациента, для создания вектора признаков относительно состояния ногтей и суставов рук и ног, в результате чего получается цифровой биомаркер изображения.
12 месяцев (наблюдение каждые 6 недель и в случае обострения)
Видео о движениях рук и тела
Временное ограничение: 12 месяцев (наблюдение каждые 6 недель и в случае обострения)
Видео заранее определенных движений руки и тела, записанные камерой смартфона пациента, для создания набора временных рядов с координатами ориентиров (полученных из видео), в результате чего получается цифровой биомаркер изображения.
12 месяцев (наблюдение каждые 6 недель и в случае обострения)
Acceptability
Временное ограничение: Baseline
Number of eligible participants who agree to participate in the study.
Baseline
Perceptions of acceptability, barriers, facilitators, and experiences (patients)
Временное ограничение: T11 (Month 12)
Semi-structured focus group interviews
T11 (Month 12)
Step counts
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Анкета по цифровой грамотности
Временное ограничение: Базовый уровень
Анкета по цифровой грамотности для технологической готовности
Базовый уровень
Genetic variants
Временное ограничение: T0 (1-Month)
Salivary DNA analysis
T0 (1-Month)
Gut microbiome
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Waist circumference, measured in centimeters.
Baseline
Clinical and Disease History Characteristics
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline, and T11 (Month 12)
Life events questionnaire for life events
Baseline, and T11 (Month 12)
Morning stiffness
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Sociedade Portuguesa de Reumatologia

Соавторы

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

Следователи

  • Главный следователь: Ana Maria Rodrigues, MD, PhD, NOVA Medical School

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

1 декабря 2027 г.

Завершение исследования (Оцененный)

1 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

8 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

13 августа 2026 г.

Первый опубликованный (Действительный)

19 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 014/2026/CENMS
  • 101095697 (Другой номер гранта/финансирования: European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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