Hypertension (HTN), Ischemic Heart Disease
Conditions
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.
Interventions
BEHAVIORALVideo Education
Videos were created using deepfake technology, utilizing AI to replicate the voice of the patients' primary physician.
OTHERControl
Standard treatment
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Number of Antihypertensive Medications Prescribed Per Participant | 4 weeks | Total number of prescribed antihypertensive medications per participant at baseline and at 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. |
Countries
South Korea
Outcome results
None listed