Technology-Enabled Remote Hypertension Management To Advance Health Equity

NCT ID: NCT06331754

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2026-03-17

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

non-blinded pragmatic cluster-randomized controlled trial with a single intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Technology-enabled blood pressure management

Intervention Type OTHER

The intervention will consist of a technology-enabled remote hypertension management program.

No intervention

Patients meeting inclusion care undergoing usual care in control clinics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Technology-enabled blood pressure management

The intervention will consist of a technology-enabled remote hypertension management program.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atman Health, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Rahul C Deo, MD PhD

Role: CONTACT

339-204-5454

Other Identifiers

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ATMANHEALTH001

Identifier Type: -

Identifier Source: org_study_id

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