AI ChatbotNCT07917000
Effect of a Web-based Application With Integrated AI Chat for Cardiovascular Risk Support
A study testing web application with AI chat and usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factors in people with AI Chatbot and Cardiovascular (CV) Risk, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- AI Chatbot, Cardiovascular (CV) Risk
- What is being tested?
- web application with AI chat and usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- Known previous major cardiovascular event (MI, stroke)
- Illiterate patients
- patient with predicted 10-year CV risk ≥20%.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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?".
- Conditions
- AI Chatbot, Cardiovascular (CV) Risk
- Being tested
- web application with AI chat, usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web application with AI chatOther
- 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.
- Educational modules (short, evidence-based content in Arabic)
- Integrated AI chat An AI-powered chatbot is integrated into the web application to provide interactive health education and respond to user inquiries regarding cardiovascular risk, lifestyle modification, dietary advices and prevention strategies. The chatbot is connected to a large language model API, enabling natural language conversations and is accessible to participants 24 hours a day.
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 clinic care follows the national prevention and management guidelines for major cardiovascular risk factorsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Web app + AI chat (Intervention arm) | Experimental | 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].
* Educational modules (short, evidence-based content in Arabic)
* Integrated AI chat An AI-powered chatbot is integrated into the web application to provide interactive health education and respond to user inquiries regarding cardiovascular risk, lifestyle modification, dietary advices and prevention strategies. The chatbot is connected to a large language model API, enabling natural language conversations and is accessible to participants 24 hours Receives: Other: web application with AI chat; Other: usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factors |
| Usual care (Control arm) | Other | 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). Receives: Other: usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute change in predicted 10-year cardiovascular risk (%) from baseline to 3 months in intervention and control groups.
Measured: 3 months
Secondary outcomes (8)
Mean change in systolic BP (mmHg)
Change in systolic blood pressure from baseline to 3 months, measured in mmHg.
Measured: 3 months
Mean change in diastolic blood pressure
Change in diastolic blood pressure from baseline to 3 months, measured in mmHg.
Measured: 3 months
Mean change in LDL cholesterol
Change in low-density lipoprotein (LDL) cholesterol level from baseline to 3 months, measured in mg/dL.
Measured: 3 months
Mean change in HDL cholesterol
Change in high-density lipoprotein (HDL) cholesterol level from baseline to 3 months, measured in mg/dL.
Measured: 3 months
Mean change in total cholesterol
Change in total cholesterol level from baseline to 3 months, measured in mg/dL.
Measured: 3 months
Mean change in HbA1c among participants with diabetes
Change in glycated hemoglobin (HbA1c) from baseline to 3 months among participants with diabetes, measured as a percentage (%).
Measured: 3 months
System Usability Scale (SUS) score
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.
Measured: 3 months
Change in medication adherence score
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start25 Oct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI ChatbotStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ibrahim Fahmy Habib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917000
- Sponsor's protocol ID
- application with AI chat &CVD
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Web-based Application With Integrated AI Chat for Cardiovascular Risk Support Versus Usual Care: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07917000
- Acronym / sponsor ID
- application with AI chat &CVD
- Conditions
- AI Chatbot, Cardiovascular (CV) Risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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?".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web app + AI chat (Intervention arm) | Experimental | Other: web application with AI chat, Other: usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factorsThe 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]. * Educational modules (short, evidence-based content in Arabic) * Integrated AI chat An AI-powered chatbot is integrated into the web application to provide interactive health education and respond to user inquiries regarding cardiovascular risk, lifestyle modification, dietary advices and prevention strategies. The chatbot is connected to a large language model API, enabling natural language conversations and is accessible to participants 24 hours |
| Usual care (Control arm) | Other | Other: usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factorsUsual 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (3 listed)
- Known previous major cardiovascular event (MI, stroke)
- Illiterate patients
- patient with predicted 10-year CV risk ≥20%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web application with AI chat• 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. * Educational modules (short, evidence-based content in Arabic) * Integrated AI chat An AI-powered chatbot is integrated into the web application to provide interactive health education and respond to user inquiries regarding cardiovascular risk, lifestyle modification, dietary advices and prevention strategies. The chatbot is connected to a large language model API, enabling natural language conversations and is accessible to participants 24 hours a day. 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]. | Other | Web app + AI chat (Intervention arm) |
| usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factorsUsual 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). | Other | Usual care (Control arm), Web app + AI chat (Intervention arm) |
Primary outcome
Mean absolute change in predicted 10-year cardiovascular risk (%) from baseline to 3 months in intervention and control groups.
Time frame: 3 months
8 secondary outcomes
Mean change in systolic BP (mmHg)
Time frame: 3 months
Mean change in diastolic blood pressure
Time frame: 3 months
Mean change in LDL cholesterol
Time frame: 3 months
Mean change in HDL cholesterol
Time frame: 3 months
Mean change in total cholesterol
Time frame: 3 months
Mean change in HbA1c among participants with diabetes
Time frame: 3 months
System Usability Scale (SUS) score
Time frame: 3 months
Change in medication adherence score
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing web application with AI chat and usual clinic care follows the national prevention and management guidelines for major cardiovascular risk factors in people with AI Chatbot and Cardiovascular (CV) Risk, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Ibrahim Habib, MSc (+201121772920, salma.ibrahim@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute change in predicted 10-year cardiovascular risk (%) from baseline to 3 months in intervention and control groups. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.