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Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition (SOFIA)

2026年10月29日 更新者：Fondation Net-Care.ch

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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).

研究类型

介入性

注册 (估计的)

1600

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 瑞士
      • Geneva、瑞士、1205
        • Geneva University Hospitals (HUG), Division of Primary Care Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：SOFIA application

Participants with a self-reported diagnosis of hypertension using the SOFIA application.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Satisfaction and Perceived Utility: Item Scores
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fondation Net-Care.ch

合作者

University Hospital, Geneva
University of Geneva, Switzerland
Haute École de Gestion de Genève (HEG-GE)

调查人员

  • 首席研究员：Mayssam Nehme, MD、Geneva University Hospitals (HUG)
  • 首席研究员：Idris Guessous, MD, PhD、Geneva University Hospitals (HUG)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年10月29日

首先提交符合 QC 标准的

2026年10月29日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SOFIA-001
  • BASEC 2026-01192 (其他标识符：Commission Cantonale d'Ethique de la Recherche (CCER), Geneva)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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