Digital Health Platform Blood Pressure Management Study

NCT ID: NCT07147413

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

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.

Conditions

Hypertension Prevention and Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

AI assistant

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

Group Type: EXPERIMENTAL

Behavioral/Digital Health Intervention

Intervention Type: 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.

Case manager

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral/Digital Health Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following criteria:

1. Aged 18 to 75 years at the time of enrollment

2. Able and willing to provide informed consent

3. Able to operate a mobile phone and interact with the digital platform

4. Willing to participate in home blood pressure monitoring

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

1. Systolic BP consistently <120 mmHg and diastolic BP <70 mmHg, based on baseline home monitoring (considered low BP not targeted in this study)

2. Pregnant or planning to become pregnant during the study period

3. Unable to operate a smartphone or digital device independently

4. Cognitive impairment or language barrier that prevents understanding of study procedures or informed consent

5. Severe comorbidities that may interfere with study participation or outcomes (e.g., advanced heart failure, end-stage renal disease)

6. Current participation in another interventional clinical study that could conflict with this protocol

7. Unwillingness to follow home blood pressure monitoring protocol or adhere to follow-up schedule

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hao-Min Cheng

Role: CONTACT

hmcheng@vghtpe.gov.tw

886-2-28757302

Other Identifiers

2024-07-021BCF

Identifier Type: -

Identifier Source: org_study_id