Technology-Enabled Remote Hypertension Management To Advance Health Equity

Not Applicable

Not yet recruiting

• Conditions: Hypertension
• Interventions: Other: Technology-enabled blood pressure management

• Registration Number: NCT06331754
• Lead Sponsor: Atman Health, Inc

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.

Detailed Description

The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of 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. Participants will be subsequently monitored for up to 12 more months.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-18
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-09-17
• Study Completion: 2026-03-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 18 years - 100 years
• uncontrolled hypertension: as defined as SBP > 140 or DBP > 90 on 2 successive clinic visits

Exclusion Criteria

• hearing impaired
• visually impaired
• cognitively impaired
• hospice care
• on hemodialysis at enrollment
• New York Heart Association Class IV heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology-enabled blood pressure management	Technology-enabled blood pressure management	The 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.

Primary Outcome Measures

Name	Time	Method
Difference in SBP change	6 months after enrollment	Difference in mean change in systolic blood pressure (SBP)

Secondary Outcome Measures

Name	Time	Method
Difference in DBP change	6 months after enrollment	Difference in mean change in diastolic blood pressure (DBP)
HEDIS proportion	6 months after enrollment	Difference in the proportion of patients meeting HEDIS definition of controlled hypertension (SBP \< 140 AND DBP \< 90) between intervention and usual care: overall and by patient group and by age, race, sex strata