Technology-Enabled Remote Hypertension Management To Advance Health Equity

Atman Health

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Other: Technology-enabled blood pressure management

Study type: Interventional

Funder types: Industry

Identifiers

NCT06331754

ATMANHEALTH001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Technology-enabled blood pressure management

Experimental group

Description:

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.

Treatment:

Other: Technology-enabled blood pressure management

No intervention

No Intervention group

Description:

Patients meeting inclusion care undergoing usual care in control clinics.