Self-Management of Blood Pressure in Resistant Hypertension
Effectiveness of Self-Management of Blood Pressure on the Management of Resistant Hypertension
1 other identifier
interventional
600
1 country
5
Brief Summary
The trial is a 12-month randomized, parallel-group study comparing three arms: (1) HBP self-management with AI chatbot support, (2) HBP self-management without AI chatbot support, and (3) usual care. The primary objective is to evaluate differences in blood pressure changes and medication compliance between groups at 6 and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
February 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
February 11, 2025
February 1, 2025
2.2 years
January 13, 2025
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HBP (systolic BP and diastolic BP) between baseline and each follow-up visit.
Primary endpoint
6 and 12 months
Secondary Outcomes (2)
Office blood pressure endpoint
6 and 12 months
Antihypertensive drug compliance endpoint
6 and 12 months
Study Arms (3)
HBP self-management with AI chatbot support
EXPERIMENTALSelf-monitoring of HBP combined with AI chatbot responses
HBP self-management without AI chatbot support
EXPERIMENTALSelf-monitoring HBP combined with telemonitoring and case management
HBP-guided usual care
NO INTERVENTIONInterventions
Integrating the practice of self-monitoring of HBP with the use of AI chatbot responses. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.
Combining self-monitoring of HBP with telemonitoring and case management. This arm includes reminders for patients to monitor their BP and take antihypertensive medications, and involves tracking BP readings over time and offering feedback. Moreover, this arm offers physician-endorsed guidance on modifying the dosage of antihypertensive medication and implementing lifestyle adjustments. It offers education on hypertension and the potential side effects of medication, as well as assistance with medication refills and scheduling appointments.
Eligibility Criteria
You may qualify if:
- ≥18 years of age
- receiving ≥3 antihypertensive medications of different classes, including a diuretic, and baseline BP \>130/80 mmHg; or receiving ≥ 4 medications regardless of BP
You may not qualify if:
- unable to conduct self-monitor BP because of cognitive dysfunction
- poor adherence to medication
- poor digital capabilities
- pregnant
- terminal disease
- an acute cardiovascular event in the previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813414, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
January 13, 2025
First Posted
February 11, 2025
Study Start
February 16, 2025
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
February 11, 2025
Record last verified: 2025-02