About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Behavioral/Digital Health Intervention
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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. \[Unit of Measure: mmHg\]; \[Method of Assessment: Home blood pressure monitoring (HBPM) using certified devices (certified by Taiwan FDA)\]
Secondary outcomes
Reduction in Systolic and Diastolic Blood Pressure at 12 Months by Home Blood Pressure Monitoring
Change in average systolic and diastolic blood pressure (SBP and DBP) from baseline to 12 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. \[Unit of Measure: mmHg\]; \[Method of Assessment: Home blood pressure monitoring (HBPM) using certified devices (certified by Taiwan FDA)\]
Improvement in Hypertension Knowledge, Attitudes, and Behaviors (KAB)
Change in participants' scores on a validated Hypertension Knowledge, Attitudes, and Behaviors (KAB) questionnaire between baseline and 6-month follow-up. The questionnaire assesses understanding of blood pressure management, behavioral intentions, and lifestyle practices. Statistical evaluation using Wilcoxon Signed-Rank Test. \[Unit of Measure: Score on KAB questionnaire\]; \[Method of Assessment: Structured questionnaire administered digitally before and after intervention\]
Adherence to 722 Blood Pressure Monitoring Protocol and Medication Compliance
Proportion of participants who complete home blood pressure monitoring in accordance with the 722 protocol and demonstrate adherence to their prescribed antihypertensive medication regimen. * BP Monitoring Adherence: At least 2 measurements per occasion, twice daily (morning and evening), for 7 consecutive days. * Medication Compliance: Taking prescribed antihypertensive medication(s) as directed (correct dosage and frequency) over the same monitoring periods. Adherence is defined as meeting both criteria at baseline and again at 6 months. This measure reflects participants' engagement with blood pressure self-monitoring behaviors and their consistency in following prescribed treatment. \[Unit of Measure: Percentage of participants\]; \[Method of Assessment: * App-based log review of BP measurements synced from devices. * Medication adherence assessed via app-based self-reports.\]
Change in Time in Therapeutic Range (TTR) for Systolic Blood Pressure
Change in the proportion of days during which a participant's home systolic blood pressure readings are within the target range (110-130 mmHg) over a 7-day observation period at baseline and at 6 months. TTR is calculated as the number of days with SBP within target range divided by total valid measurement days (minimum of 4 valid days required per observation period). Improvement in TTR reflects better blood pressure stability. \[Unit of Measure: Percentage of days in target range\]; \[Method of Assessment: Home blood pressure monitor data uploaded via app and analyzed based on Taiwan Hypertension Society's TTR definition\]
Sponsors and contacts
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Taipei Veterans General Hospital, Taiwan
Lead sponsor
Ministry of Health and Welfare, Taiwan
Collaborator