Effect of a Web-based Application With Integrated AI Chat for Cardiovascular Risk Support
Effect of a Web-based Application With Integrated AI Chat for Cardiovascular Risk Support Versus Usual Care: a Randomized Controlled Trial.
To determine the effect of a web-based application with an integrated AI chat module on 10-year cardiovascular risk score (intervention) versus usual clinic care (control) after 3 months from baseline score.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Cardiovascular diseases (CVDs), such as coronary heart disease, stroke, and peripheral vascular disease, are still among the primary causes of early mortality and long-term disability across the globe, with an estimated 17.9 million deaths and over 422 million affected individuals reported each year . The literature data showed that CVD risk factors are common in Arab countries' populations . In Egypt, coronary heart disease deaths account for 32.40% of total deaths, making Egypt the 15th highest country with coronary heart disease deaths in the world, according to the latest WHO data. Physical inactivity, consumption of high-fat foods, elevated blood pressure, tobacco use, diabetes, obesity, and lipid disorders are key contributors to the increased incidence of coronary heart disease.
Significant developments in internet and mobile technologies over the past decade offer promising opportunities to alleviate the burden of cardiovascular diseases and expand access to healthcare services.
Digital health interventions (DHIs) are technology-driven tools designed to enhance patient care and health outcomes in a safe and efficient manner. These may include smartphone apps or automated email programs. Studies by Whittaker and Wieland show that DHIs can help lower cardiovascular risk factors, supporting outcomes like smoking cessation and weight reduction and Widmer's meta-analysis found that DHIs reduced rehospitalization rates and improved cardiovascular risk score.
Natural language processing (NLP) and large language model (LLM) technologies hold significant potential for enhancing patients' access to medical knowledge. Advanced AI chatbots-such as ChatGPT-are examples of pre-trained LLMs that can engage in human-like conversations and generate coherent, contextually appropriate responses. A growing number of individuals are turning to AI chatbots instead of conventional search methods drawn by their capacity to provide personalized interactions and immediate, customized responses.
Digital interventions can improve risk factor control but evidence for AI-chat integrated web applications on predicted 10-year CV risk is limited. This RCT will compare a web application + AI chat intervention against usual clinic care on cardiovascular risk support, so that our research question is "Among adults with cardiovascular risk factors attending Kasr- Alainy family medicine clinics, does using a web application with AI chat support lead to a greater reduction in predicted 10-year cardiovascular risk compared to usual care?".
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Salma Ibrahim Habib, MSc
- Número de teléfono: +201121772920
- Correo electrónico: salma.ibrahim@kasralainy.edu.eg
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults aged 40-75 years
- At least one modifiable CV risk factor (hypertension, dyslipidemia, type 2 diabetes, current smoker).
- Access to a smartphone/computer and internet.(for the intervention group)
- Able to read Arabic and provide informed consent.
- Baseline predicted 10-year CV risk ≥5%.
Exclusion Criteria:
- Known previous major cardiovascular event (MI, stroke)
- Illiterate patients
- patient with predicted 10-year CV risk ≥20%.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Web app + AI chat (Intervention arm)
The intervention group will receive the usual clinic care and will be offered to use the app with AI chat for 3 months after explaining the purpose of the study. -An informed written consent will be taken from each participant • Web app features: User account with secure login, baseline profile (age, sex, BP, lipids, smoking, diabetes, medications) Automated calculation of 10-year cardio vascular disease risk (ASCVDR) will be done using The American College of Cardiology (ACC)/American Heart Association (AHA) Risk Estimator of ASCVD [12].
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• Web app features: User account with secure login, baseline profile (age, sex, BP, lipids, smoking, diabetes, medications) Automated calculation of 10-year cardio vascular disease risk (ASCVDR) will be done using The American College of Cardiology (ACC)/American Heart Association (AHA) Risk Estimator of ASCVD.
Medical content and responses were reviewed and supervised by the research team to ensure accuracy and adherence to international guidelines (American Heart Association [AHA] and European Society of Cardiology [ESC]. Usual care follows the national prevention and management guidelines for major cardiovascular risk factors including hypertension, dyslipidemia, diabetes, smoking, obesity, and physical inactivity. Patients typically undergo periodic clinical assessment which includes measurement of blood pressure, weight and BMI, review of lifestyle risk factors, and laboratory testing such as fasting blood glucose and lipid profile when indicated. Standard lifestyle counseling is provided in the form of brief verbal advice concerning smoking cessation, healthy diet, and increasing physical activity. Pharmacological therapy is initiated or adjusted based on the clinical assessment and guideline recommendations (e.g., antihypertensive medications, statins, antidiabetic treatment). Follow-up visits (monthly visits for 3 months). |
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Otro: Usual care (Control arm)
Usual care follows the national prevention and management guidelines for major cardiovascular risk factors including hypertension, dyslipidemia, diabetes, smoking, obesity, and physical inactivity. Patients typically undergo periodic clinical assessment which includes measurement of blood pressure, weight and BMI, review of lifestyle risk factors, and laboratory testing such as fasting blood glucose and lipid profile when indicated. Standard lifestyle counseling is provided in the form of brief verbal advice concerning smoking cessation, healthy diet, and increasing physical activity. Pharmacological therapy is initiated or adjusted based on the clinical assessment and guideline recommendations (e.g., antihypertensive medications, statins, antidiabetic treatment). Follow-up visits (monthly visits for 3 months). |
Usual care follows the national prevention and management guidelines for major cardiovascular risk factors including hypertension, dyslipidemia, diabetes, smoking, obesity, and physical inactivity. Patients typically undergo periodic clinical assessment which includes measurement of blood pressure, weight and BMI, review of lifestyle risk factors, and laboratory testing such as fasting blood glucose and lipid profile when indicated. Standard lifestyle counseling is provided in the form of brief verbal advice concerning smoking cessation, healthy diet, and increasing physical activity. Pharmacological therapy is initiated or adjusted based on the clinical assessment and guideline recommendations (e.g., antihypertensive medications, statins, antidiabetic treatment). Follow-up visits (monthly visits for 3 months). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Mean absolute change in predicted 10-year cardiovascular risk (%) from baseline to 3 months in intervention and control groups.
Periodo de tiempo: 3 months
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3 months
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean change in systolic BP (mmHg)
Periodo de tiempo: 3 months
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Change in systolic blood pressure from baseline to 3 months, measured in mmHg. |
3 months
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Mean change in diastolic blood pressure
Periodo de tiempo: 3 months
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Change in diastolic blood pressure from baseline to 3 months, measured in mmHg. |
3 months
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Mean change in LDL cholesterol
Periodo de tiempo: 3 months
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Change in low-density lipoprotein (LDL) cholesterol level from baseline to 3 months, measured in mg/dL. |
3 months
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Mean change in HDL cholesterol
Periodo de tiempo: 3 months
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Change in high-density lipoprotein (HDL) cholesterol level from baseline to 3 months, measured in mg/dL. |
3 months
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Mean change in total cholesterol
Periodo de tiempo: 3 months
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Change in total cholesterol level from baseline to 3 months, measured in mg/dL. |
3 months
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Mean change in HbA1c among participants with diabetes
Periodo de tiempo: 3 months
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Change in glycated hemoglobin (HbA1c) from baseline to 3 months among participants with diabetes, measured as a percentage (%). |
3 months
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System Usability Scale (SUS) score
Periodo de tiempo: 3 months
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Usability of the web-based application will be assessed using the 10-item System Usability Scale (SUS), with total scores ranging from 0 to 100. Higher scores indicate better perceived usability. |
3 months
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Change in medication adherence score
Periodo de tiempo: 3 months
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Change in medication adherence from baseline to 3 months, assessed using Adherence to Refills and Medications Scale (ARMS) questionnaire . It consists of 12 items covering two main domains: medication-taking behavior and prescription refill adherence Each item is scored on a 4-point Likert scale ranging from 1 (none of the time) to 4 (all of the time), with higher scores indicating lower adherence |
3 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- application with AI chat &CVD
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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