Digital Health Platform Blood Pressure Management Study

NCT07147413 | Not Yet Recruiting

• 1 other identifier: 2024-07-021BCF
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study evaluated the effectiveness of an AI health education assistant compared to case manager support in hypertension management. Key outcomes included changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), compliance with health behaviors, 722 goal achievement (monitoring, measurements, lifestyle improvements), and Technology Acceptance Model (TAM) metrics, including perceived usefulness (PU), perceived ease of use (PEU), and behavioral intention (BI). This study aims to examine whether the AI assistant group will achieve greater reductions in systolic and diastolic blood pressure compared to the case manager group. Additionally, it will evaluate whether the AI assistant group will demonstrate higher engagement in 722 goals and greater perceived ease of use. The results of this study are expected to provide further evidence supporting the potential of AI-driven interventions.

Conditions

Hypertension Prevention and Management

Keywords

Hypertension; Blood pressure; Prevention; Management

Outcome Measures

Primary Outcomes (1)

• Reduction in Systolic and Diastolic Blood Pressure at 6 Months by Home Blood Pressure Monitoring

  Change in average systolic and diastolic blood pressure (SBP and DBP) from baseline to 6 months, measured using validated automated home blood pressure monitors. Participants will follow the 722 protocol (2 readings per occasion, twice daily, over 7 consecutive days). Data are collected via the digital health platform and automatically uploaded. Outcome is calculated as the difference in mean SBP between baseline and 6-month readings. \[Unit of Measure: mmHg\]; \[Method of Assessment: Home blood pressure monitoring (HBPM) using certified devices (certified by Taiwan FDA)\]

  6 months

Secondary Outcomes (4)

• Reduction in Systolic and Diastolic Blood Pressure at 12 Months by Home Blood Pressure Monitoring

  12 months

• Improvement in Hypertension Knowledge, Attitudes, and Behaviors (KAB)

  6 months

• Adherence to 722 Blood Pressure Monitoring Protocol and Medication Compliance

  6 months

• Change in Time in Therapeutic Range (TTR) for Systolic Blood Pressure

  Baseline and 6 months

Study Arms (2)

AI assistant

EXPERIMENTAL

The AI group received app-based interventions, including medication reminders, behavioral nudges, educational quizzes, and abnormal blood pressure alerts powered by AI-driven monitoring.

Behavioral: Behavioral/Digital Health Intervention

Case manager

NO INTERVENTION

The case manager group received personalized lifestyle advice, medication reminders, and regular follow-ups from human case managers.

Interventions

Behavioral/Digital Health Intervention BEHAVIORAL

Participants in this group will utilize an AI-powered digital health management platform designed to optimize blood pressure control. The platform provides personalized medication and blood pressure measurement reminders, tailored health education, and interactive quizzes to improve hypertension awareness and engagement. Data from blood pressure monitors will be scanned and uploaded, and the system will alert participants and case managers to abnormal readings, enabling timely interventions.

AI assistant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Aged 18 to 75 years at the time of enrollment
• Able and willing to provide informed consent
• Able to operate a mobile phone and interact with the digital platform
• Willing to participate in home blood pressure monitoring

You may not qualify if:

• Participants will be excluded if they meet any of the following criteria:
• Systolic BP consistently \<120 mmHg and diastolic BP \<70 mmHg, based on baseline home monitoring (considered low BP not targeted in this study)
• Pregnant or planning to become pregnant during the study period
• Unable to operate a smartphone or digital device independently
• Cognitive impairment or language barrier that prevents understanding of study procedures or informed consent
• Severe comorbidities that may interfere with study participation or outcomes (e.g., advanced heart failure, end-stage renal disease)
• Current participation in another interventional clinical study that could conflict with this protocol
• Unwillingness to follow home blood pressure monitoring protocol or adhere to follow-up schedule

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Ministry of Health and Welfare, Taiwan: collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hao-Min Cheng

CONTACT

886-2-28757302; hmcheng@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08