NCT07210073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

September 14, 2025

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adherence to Home Blood Pressure Monitoring (HBPM)

    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).

    4 weeks

  • Medication Adherence Assessed by Pill Count

    Proportion of prescribed antihypertensive medication doses taken during the 30-day follow-up period, assessed by pill counts at the follow-up visit.

    4 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Video education

EXPERIMENTAL

Participants receive personalized video-based education developed using deepfake technology to replicate the patient's primary physician's voice, in addition to usual care.

Behavioral: Video Education

Standard Care

ACTIVE COMPARATOR

Participants receive standard treatment for ischemic heart disease and hypertension, without additional video-based education.

Other: Control

Interventions

Video EducationBEHAVIORAL

Videos were created using deepfake technology, utilizing AI to replicate the voice of the patients' primary physician.

Video education
ControlOTHER

Standard treatment

Standard Care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Hospital

Daegu, Daegu, 42601, South Korea

Location

MeSH Terms

Conditions

HypertensionMyocardial Ischemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2025

First Posted

October 7, 2025

Study Start

May 27, 2024

Primary Completion

February 4, 2025

Study Completion

March 30, 2025

Last Updated

October 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations