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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.
Background: This pilot study aimed to evaluate the effectiveness of an AI health education assistant compared with case manager support in managing hypertension. The primary focus was on changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), compliance with health behaviors, engagement in 722 goal achievement (monitoring, measurements, and 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. Methods: This two-arm, randomized controlled pilot study enrolled participants aged 18-75 years with hypertension. Participants were allocated to either the AI health education assistant group or the case manager group. The AI group received app-based interventions, including medication reminders, behavioral nudges, educational quizzes, and abnormal blood pressure alerts powered by AI-driven monitoring. The case manager group received personalized lifestyle advice, medication reminders, and regular follow-ups from human case managers. Blood pressure readings were collected at baseline and 6 months, and TAM metrics were assessed through questionnaires. Compliance with health behaviors and engagement in 722 goals were evaluated through app interaction logs. Statistical analyses included paired t-tests for within-group changes, independent t-tests for between-group comparisons, and linear regression models to assess associations between intervention type and TAM metrics, adjusting for baseline values. Discussion: This study will provide preliminary evidence on the feasibility and potential benefits of AI-driven interventions for hypertension management. It will further evaluate the AI assistant's ability to improve blood pressure control, increase engagement in 722 goals, and enhance technology acceptance. These findings will deliver important insights for clinicians and inform future clinical practice.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
September 1, 2025
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
August 29, 2025
10,000
ESTIMATED participants
Behavioral/Digital Health Intervention
BEHAVIORAL
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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