An interventional study of SOFIA application in Hypertension, Diabetes Mellitus, Type 2 and Obesity, sponsored by Fondation Net-Care.ch. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Fondation Net-Care.ch · Not applicable, Interventional, and Health services research
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.
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).
6,845 studies on the registry are indexed under Hypertension; 976 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 90 across 5,105 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Fondation Net-Care.ch as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
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%.
Time frame: From registration up to 13 months
Acceptability: French System Usability Scale (F-SUS) Score
Marginal mean French System Usability Scale (F-SUS; 10 items, composite score 0-100) across administrations. Success criterion: \>68.
Time frame: Approximately every 90 days from registration, up to 13 months
Satisfaction and Perceived Utility: Item Scores
Item-level distributions across administrations (two custom items, 5-point Likert scale).
Time frame: Approximately every 90 days from registration, up to 13 months
Willingness to Recommend: Net Promoter Score (NPS)
Net Promoter Score (NPS; 1 item, 0-10 per respondent; NPS -100 to +100).
Time frame: Approximately every 90 days from registration, up to 13 months
Physical Activity: IPAQ-SF Score (MET-minutes/week)
Score trajectory across administrations (IPAQ-SF, 7 items; MET-minutes/week).
Time frame: Approximately every 180 days from registration, up to 13 months
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) Global Score
Score trajectory across administrations (Pittsburgh Sleep Quality Index, PSQI; global score 0-21).
Time frame: Approximately every 180 days from registration, up to 13 months
Well-Being: WHO-5 Well-Being Index Score
Score trajectory across administrations (WHO-5, 5 items; raw score 0-25).
Time frame: Approximately every 90 days from registration, up to 13 months
Self-Rated Health (SRH) Score
Score trajectory across administrations (SRH, 1 item; 1-5).
Time frame: Approximately every 90 days from registration, up to 13 months
Perceived Stress: Perceived Stress Scale (PSS-4) Score
Score trajectory across administrations (PSS-4, 4 items; 0-16).
Time frame: Approximately every 90 days from registration, up to 13 months
Quality of Life: Global Quality of Life Scale Score
Score trajectory across administrations (global quality of life scale, 1 item; 0-100).
Time frame: Approximately every 90 days from registration, up to 13 months
Self-Efficacy for Chronic Disease Management: SEM-CD 6 Score
Score trajectory across administrations (SEM-CD 6, 6 items; mean 1-10).
Time frame: Approximately every 180 days from registration, up to 13 months
Condition-Specific Health Knowledge: Percentage of Correct Answers (Condition Subgroups)
Change in percentage of correct answers (health knowledge quiz).
Time frame: At registration and approximately 6 months after registration
Medication Tracking: Data Matrix Scan Confirmation Rate (Pochettes-Doses Users)
Data matrix scan confirmation rate (proportion).
Time frame: Continuously from registration, up to 13 months
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.
Time frame: Continuously from registration, up to 13 months
Self-Reported Medication Adherence: Visual Analogue Scale (VAS) Score (Condition Subgroups)
Score trajectory across administrations (visual analogue scale, 1 item; 0-100).
Time frame: Approximately every 90 days from registration, up to 13 months
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 1,349 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 13 months is below that.
Counting every sponsor, half of 1,443 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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