Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study (PPIDC)
2026년 9월 15일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
72
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Ana Maria Rodrigues, MD, PhD
- 전화번호: +351 965555061
- 이메일: ana.m.rodrigues@nms.ul.pt
연구 연락처 백업
- 이름: Cátia Gonçalves, PhD
- 이메일: catia.goncalves@nms.unl.pt
연구 장소
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Thessaloniki, 그리스
- Hipokrateion Hospital Thessaloniki
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연락하다:
- Ioanna Katsigianni, MD
- 전화번호: +30 231 089 2000
- 이메일: katsigianniioan@gmail.com
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Aveiro, 포르투갈
- Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
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연락하다:
- Anabela Barcelos, MD, PhD
- 전화번호: +351 966894176
- 이메일: barcelos.anabela@gmail.com
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Lisbon, 포르투갈
- Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
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연락하다:
- Ana Teresa Melo, MD
- 전화번호: +351 918613549
- 이메일: anateresamelo1992@gmail.com
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Porto, 포르투갈
- Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
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연락하다:
- Alexandra Bernardo, MD
- 전화번호: +351 938507343
- 이메일: alexbernardo@sapo.pt
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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System Usability Scale (SUS)
기간: 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)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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자이로스코프 센서 데이터
기간: 12개월 내내 지속
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환자의 스마트폰에서 눈에 띄지 않게 수집된 방향에 대한 자이로스코프 센서 데이터
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12개월 내내 지속
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신체 활동 강도 및 카테고리
기간: 12개월 내내 지속
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신체 활동을 측정하기 위해 환자의 스마트워치에서 눈에 띄지 않게 수집된 신체 활동 강도 및 신체 활동 카테고리.
강도와 카테고리는 스마트워치에서 제공하는 기능입니다.
환자는 매일 스마트워치를 착용합니다.
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12개월 내내 지속
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스트레스(디지털)
기간: 12개월 내내 지속
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스트레스 규모를 측정하기 위해 환자의 스마트워치에서 눈에 띄지 않게 수집된 스트레스 수준.
스마트워치에서 제공하는 기능입니다.
환자는 매일 스마트워치를 착용합니다.
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12개월 내내 지속
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자는 시간
기간: 12개월 내내 지속
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환자의 스마트워치에서 눈에 띄지 않게 수집된 수면 시간(시간)
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12개월 내내 지속
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수면형
기간: 12개월 내내 지속
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환자의 스마트워치에서 눈에 띄지 않게 수집된 수면 유형(%)
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12개월 내내 지속
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손과 발 사진
기간: 12개월(6주마다 및 발적의 경우 후속 조치)
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환자의 스마트폰 카메라로 촬영한 환자의 손과 발 이미지를 통해 손과 발가락의 손톱과 관절 상태에 대한 특징 벡터를 생성하여 이미징 디지털 바이오마커를 생성합니다.
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12개월(6주마다 및 발적의 경우 후속 조치)
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손과 몸의 움직임 동영상
기간: 12개월(6주마다 및 발적의 경우 후속 조치)
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환자의 스마트폰 카메라로 미리 지정된 손과 몸의 움직임을 비디오로 기록하여 랜드마크 좌표(비디오에서 얻은)를 사용하여 일련의 시계열을 생성하여 이미징 디지털 바이오마커를 생성합니다.
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12개월(6주마다 및 발적의 경우 후속 조치)
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Acceptability
기간: 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)
기간: 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
기간: Continuous, throughout 12 months
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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
기간: Continuous, throughout 12 months
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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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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.
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Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
기간: 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)
기간: 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
기간: 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
기간: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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
기간: Continuous throughout 12 months
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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
기간: Continuous throughout 12 months
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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
기간: Continuous throughout 12 months
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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)
기간: Continuous, through 12 months of follow-up
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Number of discrete user sessions or app log-ins over the study period, indicating engagement consistency and sustained participation.
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Continuous, through 12 months of follow-up
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Session Duration (iPROLEPSIS apps)
기간: Continuous, throughout 11 months
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Dwell time within each application, i.e., duration of each user session, in minutes.
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Continuous, throughout 11 months
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Feature Access Rate (iPROLEPSIS Apps)
기간: Continuous throughout 12 months
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Number of times users access specific app features or modules, reflecting breadth and depth of feature engagement.
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Continuous throughout 12 months
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Task Completion Rate (iPROLEPSIS Apps)
기간: Continuous throughout 12 months
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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)
기간: Continuous throughout 12 months
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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)
기간: Continuous throughout 12 months
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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)
기간: Continuous throughout 12 months
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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)
기간: Continuous throughout 12 months
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Frequency and quantity of user-initiated data input, indicating active engagement and perceived app utility
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Continuous throughout 12 months
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Number of Dashboard Sessions Logged (HCP Dashboard)
기간: Continuous throughout 12 months
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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
기간: 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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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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디지털 리터러시 설문지
기간: 기준선
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기술 준비도를 위한 디지털 리터러시 설문지
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기준선
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Genetic variants
기간: T0 (1-Month)
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Salivary DNA analysis
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T0 (1-Month)
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Gut microbiome
기간: T0 (1-Month) and T3 (4-Month)
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Stool analysis to extract bacterial DNA using 16S sequencing
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T0 (1-Month) and T3 (4-Month)
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Inflammatory blood marker
기간: 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
기간: Baseline
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Waist circumference, measured in centimeters.
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Baseline
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Clinical and Disease History Characteristics
기간: Baseline
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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.
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Baseline
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Demographics
기간: Baseline
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Ana Maria Rodrigues, MD, PhD, NOVA Medical School
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 1일
기본 완료 (추정된)
기본 완료
2027년 12월 1일
연구 완료 (추정된)
연구 완료
2027년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 8일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 15일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 014/2026/CENMS
- 101095697 (기타 보조금/기금 번호: European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .