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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Geneva, Suíça, 1205
- Geneva University Hospitals (HUG), Division of Primary Care Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
User Retention: Proportion of Participants With Sustained Inactivity (Attrition)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Satisfaction and Perceived Utility: Item Scores
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Distúrbios Nutricionais
- Atributos da doença
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Excesso de peso
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Adesão e Cumprimento do Tratamento
- Comportamento de saúde
- Conformidade do paciente
- Aceitação dos Cuidados de Saúde pelo Paciente
- Obesidade
- Hipertensão
- Diabetes Mellitus, Tipo 2
- Doença crônica
- Adesão à Medicação
Outros números de identificação do estudo
- SOFIA-001
- BASEC 2026-01192 (Outro identificador: Commission Cantonale d'Ethique de la Recherche (CCER), Geneva)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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