Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition (SOFIA)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Geneva, Svizzera, 1205
- Geneva University Hospitals (HUG), Division of Primary Care Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: SOFIA application
Participants with a self-reported diagnosis of hypertension using the 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Satisfaction and Perceived Utility: Item Scores
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Mayssam Nehme, MD, Geneva University Hospitals (HUG)
- Investigatore principale: Idris Guessous, MD, PhD, Geneva University Hospitals (HUG)
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Malattie vascolari
- Malattia cardiovascolare
- Processi patologici
- Disturbi della nutrizione
- Attributi della malattia
- Malattie metaboliche
- Ipernutrizione
- Peso corporeo
- Disturbi del metabolismo del glucosio
- Diabete mellito
- Sovrappeso
- Condizioni patologiche, segni e sintomi
- Comportamento
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Aderenza e conformità al trattamento
- Comportamento sanitario
- Conformità del paziente
- Accettazione dell'assistenza sanitaria da parte del paziente
- Obesità
- Ipertensione
- Diabete mellito, tipo 2
- Malattia cronica
- Aderenza ai farmaci
Altri numeri di identificazione dello studio
- SOFIA-001
- BASEC 2026-01192 (Altro identificatore: Commission Cantonale d'Ethique de la Recherche (CCER), Geneva)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
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