Technology-Enabled Remote Hypertension Management To Advance Health Equity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Technology-enabled blood pressure management

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 Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahul C Deo, MD PhD; Phone Number: 339-204-5454; Email: rahul@atmanhealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Technology-enabled blood pressure management; The intervention will consist of a technology-enabled remote hypertension management program.
No Intervention: No intervention; Patients meeting inclusion care undergoing usual care in control clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in SBP change	Difference in mean change in systolic blood pressure (SBP)	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEDIS proportion	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	6 months after enrollment
Difference in DBP change	Difference in mean change in diastolic blood pressure (DBP)	6 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home measured change in SBP and DBP	Home measured change in blood pressure in intervention group - more accurately measured: overall and by patient group	6 months
Patient satisfaction	A patient satisfaction survey with questions similar to the Consumer Assessment of Healthcare Providers and Systems will be used.	6 months
Provider satisfaction	A survey instrument will be developed and administered to assess provider satisfaction with having a remote team manage their patients.	6 months
Mean time required per patient for provider	Cumulative time in minutes for all interactions, including documentation.	6 months
Mean time required per patient for navigator	Cumulative time in minutes for all interactions, including documentation.	6 months
Proportion of patients measuring blood pressure at directed frequency	Proportion of patients measuring blood pressure at least twice a day during active management period.	6 months
Resource utilization	Difference in resource utilization between intervention and usual care for different patient groups using claims data.	18 months

Collaborators and Investigators

• Sponsor: Atman Health, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2024
• Primary Completion (Estimated): September 17, 2025
• Study Completion (Estimated): March 17, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: ATMANHEALTH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No