Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study (PPIDC)
2026年9月15日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ana Maria Rodrigues, MD, PhD
- 電話番号：+351 965555061
- メール：ana.m.rodrigues@nms.ul.pt
研究連絡先のバックアップ
- 名前：Cátia Gonçalves, PhD
- メール：catia.goncalves@nms.unl.pt
研究場所
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Thessaloniki、ギリシャ
- Hipokrateion Hospital Thessaloniki
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コンタクト：
- Ioanna Katsigianni, MD
- 電話番号：+30 231 089 2000
- メール：katsigianniioan@gmail.com
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Aveiro、ポルトガル
- Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
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コンタクト：
- Anabela Barcelos, MD, PhD
- 電話番号：+351 966894176
- メール：barcelos.anabela@gmail.com
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Lisbon、ポルトガル
- Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
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コンタクト：
- Ana Teresa Melo, MD
- 電話番号：+351 918613549
- メール：anateresamelo1992@gmail.com
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Porto、ポルトガル
- Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
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コンタクト：
- Alexandra Bernardo, MD
- 電話番号：+351 938507343
- メール：alexbernardo@sapo.pt
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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System Usability Scale (SUS)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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ジャイロスコープセンサーデータ
時間枠：12ヶ月間継続
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患者のスマートフォンから目立たないように収集された方位に関するジャイロスコープ センサー データ
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12ヶ月間継続
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身体活動の強度とカテゴリー
時間枠：12ヶ月間継続
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身体活動強度と身体活動カテゴリは、身体活動を測定するために患者のスマートウォッチから目立たないように収集されます。
強度とカテゴリはスマートウォッチが提供する機能です。
患者はスマートウォッチを毎日着用します
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12ヶ月間継続
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ストレス（デジタル）
時間枠：12ヶ月間継続
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ストレスレベルを患者のスマートウォッチから目立たないように収集し、体重計でストレスを測定します。
これはスマートウォッチが提供する機能です。
患者はスマートウォッチを毎日着用します
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12ヶ月間継続
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睡眠時間
時間枠：12ヶ月間継続
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患者のスマートウォッチから目立たないように睡眠時間（時間）を収集
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12ヶ月間継続
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睡眠タイプ
時間枠：12ヶ月間継続
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患者のスマートウォッチから目立たないように収集された睡眠タイプ (%)
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12ヶ月間継続
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手と足の写真
時間枠：12 か月 (6 週間ごとのフォローアップおよび再燃の場合)
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患者のスマートフォンのカメラで撮影された患者の手と足の画像。爪と手と足の関節の状態に関する特徴ベクトルを生成し、イメージングデジタルバイオマーカーを生成します。
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12 か月 (6 週間ごとのフォローアップおよび再燃の場合)
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手と体の動きのビデオ
時間枠：12 か月 (6 週間ごとのフォローアップおよび再燃の場合)
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患者のスマートフォンのカメラで記録された、事前に指定された手と体の動きのビデオ。（ビデオから取得された）ランドマーク座標を含む一連の時系列が生成され、イメージングデジタルバイオマーカーが生成されます。
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12 か月 (6 週間ごとのフォローアップおよび再燃の場合)
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Acceptability
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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デジタルリテラシーアンケート
時間枠：ベースライン
|
テクノロジーの準備のためのデジタル リテラシー アンケート
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ベースライン
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Genetic variants
時間枠：T0 (1-Month)
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Salivary DNA analysis
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T0 (1-Month)
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Gut microbiome
時間枠：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
時間枠：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
時間枠：Baseline
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Waist circumference, measured in centimeters.
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Baseline
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Clinical and Disease History Characteristics
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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
時間枠：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
時間枠：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
時間枠：Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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
時間枠：Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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)
時間枠：Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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)
時間枠：Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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
時間枠：Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Ana Maria Rodrigues, MD, PhD、NOVA Medical School
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年8月8日
QC基準を満たした最初の提出物
2026年8月13日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月16日
QC基準を満たした最後の更新が送信されました
2026年9月15日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 014/2026/CENMS
- 101095697 (その他の助成金/資金番号：European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。