Video Assisted Education to Improve Blood Pressure Control in Ischemic Heart Disease Patients With Hypertension: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Adherence to Home Blood Pressure Monitoring (HBPM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Video education
Participants receive personalized video-based education developed using deepfake technology to replicate the patient's primary physician's voice, in addition to usual care.
干预措施: Video Education (Behavioral)
Standard Care
Participants receive standard treatment for ischemic heart disease and hypertension, without additional video-based education.
干预措施: Control (Other)
结局指标
主要结局
Adherence to Home Blood Pressure Monitoring (HBPM)
时间窗: 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
时间窗: 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.
次要结局
- Change in Office Systolic Blood Pressure From Baseline to 4 Weeks(4 weeks)
- Change in Office Diastolic Blood Pressure From Baseline to 4 Weeks(4 weeks)
- Difference in Mean Systolic Blood Pressure Between Home BP Monitoring and 24-Hour Ambulatory Monitoring(4 weeks)
- Difference in Mean Diastolic Blood Pressure Between Home BP Monitoring and 24-Hour Ambulatory Monitoring(4 weeks)
- Number of Antihypertensive Medications Prescribed Per Participant(4 weeks)
- Distribution of Antihypertensive Medication Classes Used(4 weeks)