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Clinical Trials/NCT06331754
NCT06331754
Not yet recruiting
Not Applicable

Technology-Enabled Remote Hypertension Management To Advance Health Equity

Atman Health, Inc0 sites1,500 target enrollmentMarch 18, 2024
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Atman Health, Inc
Enrollment
1500
Primary Endpoint
Difference in SBP change
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2024
End Date
March 17, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Atman Health, Inc
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference in SBP change

Time Frame: 6 months after enrollment

Difference in mean change in systolic blood pressure (SBP)

Secondary Outcomes

  • Difference in DBP change(6 months after enrollment)
  • HEDIS proportion(6 months after enrollment)

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