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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Geneva, Suiza, 1205
- Geneva University Hospitals (HUG), Division of Primary Care Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Satisfaction and Perceived Utility: Item Scores
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: At registration and approximately 6 months after registration
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mayssam Nehme, MD, Geneva University Hospitals (HUG)
- Investigador principal: Idris Guessous, MD, PhD, Geneva University Hospitals (HUG)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Trastornos Nutricionales
- Atributos de la enfermedad
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Obesidad
- Hipertensión
- Diabetes Mellitus, Tipo 2
- Enfermedad crónica
- Adherencia a la medicación
Otros números de identificación del estudio
- SOFIA-001
- BASEC 2026-01192 (Otro identificador: Commission Cantonale d'Ethique de la Recherche (CCER), Geneva)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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