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HypertensionSOFIANCT07916753

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

A study testing SOFIA application in people with Hypertension and Diabetes Mellitus, Type 2, run by Fondation Net-Care.ch at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Diabetes Mellitus, Type 2, Obesity
What is being tested?
SOFIA application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
1 siteSwitzerland
Study dates
Nov 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Current participation in another interventional clinical trial
  • Inability to provide digital informed consent
  • Participation in the SOFIA beta testing program

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site

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

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Read the 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).

Being tested
SOFIA application
Keywords
Mobile Health, Artificial Intelligence, Self-Management, Medication Adherence, Chronic Disease
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Obesity, Medication Adherence, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOFIA applicationBehavioural

    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.

Study groups in NCT07916753
Study groupRoleWhat they receive
SOFIA applicationExperimentalParticipants with a self-reported diagnosis of hypertension using the SOFIA application.
Receives: Behavioral: SOFIA application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User Retention: Proportion of Participants With Sustained Inactivity (Attrition)

    Attrition (proportion of participants), with sustained inactivity defined as no session for 90 consecutive days. Success criterion: attrition <20%.

    Measured: From registration up to 13 months

  2. Acceptability: French System Usability Scale (F-SUS) Score

    Marginal mean French System Usability Scale (F-SUS; 10 items) score across administrations. Score 0-100; higher scores indicate better usability. Success criterion: >68.

    Measured: Approximately every 90 days from registration, up to 13 months

Secondary outcomes (13)

  1. Satisfaction and Perceived Utility: Item Scores

    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).

    Measured: Approximately every 90 days from registration, up to 13 months

  2. Willingness to Recommend: Net Promoter Score (NPS)

    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.

    Measured: Approximately every 90 days from registration, up to 13 months

  3. Physical Activity: IPAQ-SF Score (MET-minutes/week)

    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.

    Measured: Approximately every 180 days from registration, up to 13 months

  4. Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) Global Score

    Score trajectory across administrations (Pittsburgh Sleep Quality Index, PSQI). Global score 0-21; higher scores indicate worse sleep quality.

    Measured: Approximately every 180 days from registration, up to 13 months

  5. Well-Being: WHO-5 Well-Being Index Score

    Score trajectory across administrations (World Health Organization Well-Being Index, WHO-5; 5 items). Raw score 0-25; higher scores indicate better well-being.

    Measured: Approximately every 90 days from registration, up to 13 months

  6. Self-Rated Health (SRH) Score

    Score trajectory across administrations (Self-Rated Health, SRH; 1 item). Score 1-5 (1 = excellent, 5 = poor); higher scores indicate worse self-rated health.

    Measured: Approximately every 90 days from registration, up to 13 months

  7. Perceived Stress: Perceived Stress Scale (PSS-4) Score

    Score trajectory across administrations (Perceived Stress Scale, 4-item version, PSS-4). Score 0-16; higher scores indicate greater perceived stress.

    Measured: Approximately every 90 days from registration, up to 13 months

  8. Quality of Life: Global Quality of Life Scale Score

    Score trajectory across administrations (Global Quality of Life Scale; 1 item). Score 0-100; higher scores indicate better quality of life.

    Measured: Approximately every 90 days from registration, up to 13 months

  9. Self-Efficacy for Chronic Disease Management: SEM-CD 6 Score

    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.

    Measured: Approximately every 180 days from registration, up to 13 months

  10. Condition-Specific Health Knowledge: Percentage of Correct Answers (Condition Subgroups)

    Change in percentage of correct answers on a health knowledge quiz (0-100%; higher values indicate better knowledge).

    Measured: At registration and approximately 6 months after registration

  11. Medication Tracking: Data Matrix Scan Confirmation Rate (Pochettes-Doses Users)

    Data matrix scan confirmation rate (proportion).

    Measured: Continuously from registration, up to 13 months

  12. Medication-Tracking Gaps: Proportion of Missed or Mistimed Scan Events (Condition Subgroups)

    Proportion of missed or mistimed scan events among actively engaged pochettes-doses users.

    Measured: Continuously from registration, up to 13 months

  13. Self-Reported Medication Adherence: Visual Analogue Scale (VAS) Score (Condition Subgroups)

    Score trajectory across administrations (medication adherence visual analogue scale, VAS; 1 item). Score 0-100; higher scores indicate better adherence.

    Measured: Approximately every 90 days from registration, up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916753
Sponsor's protocol ID
SOFIA-001
Other IDs
BASEC 2026-01192
Acronym
SOFIA
Status last verified
Nov 2026
First submitted
29 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing SOFIA application in people with Hypertension and Diabetes Mellitus, Type 2, run by Fondation Net-Care.ch at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User Retention: Proportion of Participants With Sustained Inactivity (Attrition) (time frame: From registration up to 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07916753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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