Video Education to Improve Blood Pressure Control in Patients With Ischemic Heart Disease and Hypertension (V-EDUCATE)

Not Applicable

Completed

• Conditions: Hypertension (HTN); Ischemic Heart Disease

• Registration Number: NCT07210073
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

We investigated whether video-based education using deepfake technology could improve blood pressure measurement adherence and medication adherence in patients with ischemic heart disease accompanied by hypertension.

Detailed Description

Hypertension is a major risk factor for recurrent cardiovascular events in patients with ischemic heart disease, yet adherence to home blood pressure monitoring and prescribed medications remains suboptimal. Personalized and engaging educational strategies may help to improve adherence behaviors in this population.

This randomized controlled trial investigates the effectiveness of a video-based educational program, developed with deepfake technology, to deliver individualized health information. Participants are randomly assigned to either the intervention group, which receives the video education in addition to usual care, or the control group, which receives usual care alone.

The primary outcomes are adherence to home blood pressure monitoring and medication adherence after one month. Secondary outcomes include changes in office and home blood pressure, as well as 24-hour ambulatory blood pressure monitoring. The results of this study may provide evidence for scalable, technology-assisted strategies to enhance adherence and improve blood pressure control in high-risk cardiovascular patients.

Study Timeline

• Study Start: 2024-05-27
• Status Verified: 2025-02
• Primary Completion: 2025-02-04
• Study Completion: 2025-03-30
• Study First Submitted: 2025-09-14
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Adults aged 19 years or older, both male and female, with a history of hypertension or who have taken antihypertensive medication at least once, satisfying one or more of the following ischemic heart disease conditions (PCI, CABG, CAD >50% by CCT or CAG), or patients with a history of hypertension or currently taking antihypertensive medication.
• Individuals who have voluntarily provided written consent to participate in this clinical trial.

Exclusion Criteria

• SBP < 90 mmHg or DBP < 50 mmHg
• Individuals intolerant to all antihypertensive medications
• Patients with heart failure due to other causes, Pregnant women, those suspected of being pregnant, or those who are breastfeeding
• Patients whom the investigator deems legally or mentally unfit to participate in the clinical trial
• Patients who have participated in another clinical study involving investigational drugs within 4 weeks prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to Home Blood Pressure Monitoring (HBPM)	4 weeks	Proportion of days during the 30-day follow-up period in which participants recorded four BP measurements per day (two in the morning, two in the evening) using a validated home BP device (InBody BP170).
Medication Adherence Assessed by Pill Count	4 weeks	Proportion of prescribed antihypertensive medication doses taken during the 30-day follow-up period, assessed by pill counts at the follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Change in Office Systolic Blood Pressure From Baseline to 4 Weeks	4 weeks	Mean change in systolic blood pressure (SBP) measured in clinic using a standardized sphygmomanometer at baseline and 4 weeks.
Change in Office Diastolic Blood Pressure From Baseline to 4 Weeks	4 weeks	Mean change in diastolic blood pressure (DBP) measured in clinic using a standardized sphygmomanometer at baseline and 4 weeks.
Difference in Mean Systolic Blood Pressure Between Home BP Monitoring and 24-Hour Ambulatory Monitoring	4 weeks	Difference between mean SBP values obtained from home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).
Difference in Mean Diastolic Blood Pressure Between Home BP Monitoring and 24-Hour Ambulatory Monitoring	4 weeks	Difference between mean DBP values obtained from HBPM and ABPM.
Number of Antihypertensive Medications Prescribed Per Participant	4 weeks	Total number of prescribed antihypertensive medications per participant at baseline and at 4 weeks.
Distribution of Antihypertensive Medication Classes Used	4 weeks	Proportion of participants prescribed each class of antihypertensive medication (RAAS inhibitors, beta-blockers, calcium channel blockers, diuretics, etc.) at baseline and 4 weeks.

Trial Locations

Locations (1)

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Daegu, South Korea