Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition (SOFIA)
SOFIA: Evaluation of the Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
The SOFIA study evaluates a web-based health application for people living with one or more chronic conditions. The study aims to find out whether the SOFIA application is useful, easy to use, and used over time by participants.
The SOFIA application offers tools to support the day-to-day management of health: lifestyle challenges, health data entry and personal tracking (e.g., blood pressure, weight), medication tracking for people using pochettes-doses (pharmacy-prepared unit-dose packets), and an AI conversational assistant providing general health information. The application does not make diagnoses, give personalized medical advice, or recommend treatment. It complements usual medical care but does not replace it.
The study first enrolls people with hypertension, then, subject to ethics committee approval, people with type 2 diabetes and obesity.
Participation takes place entirely online, through the SOFIA application, accessible from a web browser (smartphone, tablet, or computer). There are no in-person visits. Participants use the application freely, at their own pace, until the end of the study. Short questionnaires (most take 1 to 3 minutes) are offered in the application during the study, and a final questionnaire (about 20 minutes) at the end.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Regulatory classification: Other Clinical Trial according to the Swiss Ordinance on Clinical Trials (ClinO, Chapter 4), Risk Category A.
Deployment model: All application users are study participants; the digital informed consent also serves as the terms of use. Enrolment is rolling from application launch and opens by condition as its content is integrated, starting with hypertension.
Data collection: Usage data (sessions, feature use, AI interactions, scan events) are collected server-side. Validated instruments are delivered individually within the application on a rotating micro-assessment schedule, with a final assessment administering all instruments simultaneously.
Safety: Adverse events can be reported at any time within the application. An urgency classifier triggers the display of emergency numbers (144 / 143) when needed.
Statistical analysis: Acceptability is tested formally (one-sided α = 0.025, mixed-effects model). Retention is evaluated descriptively, with Kaplan-Meier analysis as supportive analysis. Secondary endpoints are analyzed with mixed-effects models or generalized estimating equations. Sensitivity analyses include multiple imputation, a per-protocol set, and tipping-point analyses. Sex-disaggregated analyses are planned across all endpoints.
Data protection: Data are coded, hosted in Switzerland, and encrypted (AES-256 GCM).
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Geneva, Швейцария, 1205
- Geneva University Hospitals (HUG), Division of Primary Care Medicine
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged 18 years or older
- Resident or worker in the canton of Geneva
- Access to a device with a web browser and internet connection (smartphone, tablet, or computer)
- Ability to read and understand French sufficiently to use the application and complete study questionnaires
- Willing and able to comply with the study procedures
- Digital informed consent (e-consent) provided
- Self-reported diagnosis of hypertension
Exclusion Criteria:
- Current participation in another interventional clinical trial
- Inability to provide digital informed consent
- Participation in the SOFIA beta testing program
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: SOFIA application
Participants with a self-reported diagnosis of hypertension using the SOFIA application. |
AI-assisted health application accessible on any device with a web browser (smartphone, tablet, or computer), comprising: (1) gamified lifestyle challenges; (2) health data entry and personal tracking; (3) medication tracking via pochettes-doses data matrix scanning; (4) an AI conversational assistant providing general, evidence-based health information. A complement to, not a replacement for, usual medical care. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
Временное ограничение: From registration up to 13 months
|
Attrition (proportion of participants), with sustained inactivity defined as no session for 90 consecutive days. Success criterion: attrition <20%. |
From registration up to 13 months
|
|
Acceptability: French System Usability Scale (F-SUS) Score
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Marginal mean French System Usability Scale (F-SUS; 10 items, composite score 0-100) across administrations. Success criterion: >68. |
Approximately every 90 days from registration, up to 13 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Satisfaction and Perceived Utility: Item Scores
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Item-level distributions across administrations (two custom items, 5-point Likert scale). |
Approximately every 90 days from registration, up to 13 months
|
|
Willingness to Recommend: Net Promoter Score (NPS)
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Net Promoter Score (NPS; 1 item, 0-10 per respondent; NPS -100 to +100). |
Approximately every 90 days from registration, up to 13 months
|
|
Physical Activity: IPAQ-SF Score (MET-minutes/week)
Временное ограничение: Approximately every 180 days from registration, up to 13 months
|
Score trajectory across administrations (IPAQ-SF, 7 items; MET-minutes/week). |
Approximately every 180 days from registration, up to 13 months
|
|
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) Global Score
Временное ограничение: Approximately every 180 days from registration, up to 13 months
|
Score trajectory across administrations (Pittsburgh Sleep Quality Index, PSQI; global score 0-21). |
Approximately every 180 days from registration, up to 13 months
|
|
Well-Being: WHO-5 Well-Being Index Score
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Score trajectory across administrations (WHO-5, 5 items; raw score 0-25). |
Approximately every 90 days from registration, up to 13 months
|
|
Self-Rated Health (SRH) Score
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Score trajectory across administrations (SRH, 1 item; 1-5). |
Approximately every 90 days from registration, up to 13 months
|
|
Perceived Stress: Perceived Stress Scale (PSS-4) Score
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Score trajectory across administrations (PSS-4, 4 items; 0-16). |
Approximately every 90 days from registration, up to 13 months
|
|
Quality of Life: Global Quality of Life Scale Score
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Score trajectory across administrations (global quality of life scale, 1 item; 0-100). |
Approximately every 90 days from registration, up to 13 months
|
|
Self-Efficacy for Chronic Disease Management: SEM-CD 6 Score
Временное ограничение: Approximately every 180 days from registration, up to 13 months
|
Score trajectory across administrations (SEM-CD 6, 6 items; mean 1-10). |
Approximately every 180 days from registration, up to 13 months
|
|
Condition-Specific Health Knowledge: Percentage of Correct Answers (Condition Subgroups)
Временное ограничение: At registration and approximately 6 months after registration
|
Change in percentage of correct answers (health knowledge quiz). |
At registration and approximately 6 months after registration
|
|
Medication Tracking: Data Matrix Scan Confirmation Rate (Pochettes-Doses Users)
Временное ограничение: Continuously from registration, up to 13 months
|
Data matrix scan confirmation rate (proportion). |
Continuously from registration, up to 13 months
|
|
Medication-Tracking Gaps: Proportion of Missed or Mistimed Scan Events (Condition Subgroups)
Временное ограничение: Continuously from registration, up to 13 months
|
Proportion of missed or mistimed scan events among actively engaged pochettes-doses users. |
Continuously from registration, up to 13 months
|
|
Self-Reported Medication Adherence: Visual Analogue Scale (VAS) Score (Condition Subgroups)
Временное ограничение: Approximately every 90 days from registration, up to 13 months
|
Score trajectory across administrations (visual analogue scale, 1 item; 0-100). |
Approximately every 90 days from registration, up to 13 months
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Mayssam Nehme, MD, Geneva University Hospitals (HUG)
- Главный следователь: Idris Guessous, MD, PhD, Geneva University Hospitals (HUG)
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Патологические процессы
- Расстройства питания
- Атрибуты болезни
- Метаболические заболевания
- Переедание
- Масса тела
- Нарушения метаболизма глюкозы
- Сахарный диабет
- Избыточный вес
- Патологические состояния, признаки и симптомы
- Поведение
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Приверженность и соблюдение режима лечения
- Поведение в отношении здоровья
- Соблюдение пациентом
- Принятие пациентом медицинской помощи
- Ожирение
- Гипертония
- Сахарный диабет, тип 2
- Хроническое заболевание
- Приверженность к лечению
Другие идентификационные номера исследования
- SOFIA-001
- BASEC 2026-01192 (Другой идентификатор: Commission Cantonale d'Ethique de la Recherche (CCER), Geneva)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Participants may optionally consent to the reuse of their coded data in other research projects, subject to ethics committee approval. The scope of data, sharing modalities, and data transfer agreements have yet to be defined.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .