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

October 29, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOFIA application

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction and Perceived Utility: Item Scores
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Net-Care.ch

Collaborators

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

Investigators

  • Principal Investigator: Mayssam Nehme, MD, Geneva University Hospitals (HUG)
  • Principal Investigator: Idris Guessous, MD, PhD, Geneva University Hospitals (HUG)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

October 29, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 29, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOFIA-001
  • BASEC 2026-01192 (Other Identifier: Commission Cantonale d'Ethique de la Recherche (CCER), Geneva)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe