Technology-Enabled Remote Hypertension Management To Advance Health Equity
1 other identifier
interventional
1,500
0 countries
N/A
Brief Summary
The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Mar 2024
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
March 18, 2024
CompletedStudy Start
First participant enrolled
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2026
CompletedMarch 26, 2024
March 1, 2024
1.5 years
March 18, 2024
March 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in SBP change
Difference in mean change in systolic blood pressure (SBP)
6 months after enrollment
Secondary Outcomes (2)
HEDIS proportion
6 months after enrollment
Difference in DBP change
6 months after enrollment
Other Outcomes (7)
Home measured change in SBP and DBP
6 months
Patient satisfaction
6 months
Provider satisfaction
6 months
- +4 more other outcomes
Study Arms (2)
Technology-enabled blood pressure management
EXPERIMENTALThe intervention will consist of a technology-enabled remote hypertension management program. Participants will be given a cellular blood pressure (BP) cuff and patients with heart failure and chronic kidney disease stage 3b-5 will be given a scale also. Patients will undergo a series of protocolized software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure \< 130 mmHg and diastolic blood pressure \< 80 mmHg. Patients will be subsequently monitored for up to 12 more months. If their blood pressure increases, they can re-enter active management.
No intervention
NO INTERVENTIONPatients meeting inclusion care undergoing usual care in control clinics.
Interventions
The intervention will consist of a technology-enabled remote hypertension management program.
Eligibility Criteria
You may qualify if:
- years - 100 years
- uncontrolled hypertension: as defined as SBP \> 140 or DBP \> 90 on 2 successive clinic visits
You may not qualify if:
- hearing impaired
- visually impaired
- cognitively impaired
- hospice care
- on hemodialysis at enrollment
- New York Heart Association Class IV heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 26, 2024
Study Start
March 18, 2024
Primary Completion
September 17, 2025
Study Completion
March 17, 2026
Last Updated
March 26, 2024
Record last verified: 2024-03