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

29. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

1600

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SOFIA application

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Satisfaction and Perceived Utility: Item Scores
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fondation Net-Care.ch

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

29. oktober 2026

Først innsendt som oppfylte QC-kriteriene

29. oktober 2026

Først lagt ut (Faktiske)

4. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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