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

November 4, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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) score across administrations. Score 0-100; higher scores indicate better usability. Success criterion: >68.
Approximately every 90 days from registration, up to 13 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Satisfaction and Perceived Utility: Item Scores
Time Frame: Approximately every 90 days from registration, up to 13 months

Item-level distributions across administrations (two study-specific items: overall satisfaction and perceived utility; 5-point Likert scale, 1-5; higher scores indicate greater satisfaction or perceived utility).
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; higher scores indicate greater willingness to recommend). NPS = percentage of promoters minus percentage of detractors; range -100 to +100, higher is better.
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 (International Physical Activity Questionnaire - Short Form, IPAQ-SF; 7 items). Total physical activity in MET-minutes/week; minimum 0, no fixed maximum; higher values indicate more physical activity.
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; higher scores indicate worse sleep quality.
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 (World Health Organization Well-Being Index, WHO-5; 5 items). Raw score 0-25; higher scores indicate better well-being.
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 (Self-Rated Health, SRH; 1 item). Score 1-5 (1 = excellent, 5 = poor); higher scores indicate worse self-rated health.
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 (Perceived Stress Scale, 4-item version, PSS-4). Score 0-16; higher scores indicate greater perceived stress.
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). Score 0-100; higher scores indicate better quality of life.
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 (Self-Efficacy for Managing Chronic Disease 6-Item Scale, SEM-CD 6). Mean score 1-10; higher scores indicate greater self-efficacy.
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 on a health knowledge quiz (0-100%; higher values indicate better knowledge).
At registration and approximately 6 months after registration
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 (medication adherence visual analogue scale, VAS; 1 item). Score 0-100; higher scores indicate better adherence.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondation Net-Care.ch

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
University of Geneva, Switzerland
Haute École de Gestion de Genève (HEG-GE)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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