Technology-Enabled Remote Hypertension Management To Advance Health Equity

Hypertension Clinical Trial

Official title:

Technology-Enabled Remote Hypertension Management To Advance Health Equity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06331754
• Other study ID #: ATMANHEALTH001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: March 17, 2026

Study information

• Verified date: March 2024
• Source: Atman Health, Inc
• Contact: Rahul C Deo, MD PhD
• Phone: 339-204-5454
• Email: rahul[@]atmanhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: March 17, 2026
• Est. primary completion date: September 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Technology-enabled blood pressure management
The intervention will consist of a technology-enabled remote hypertension management program.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Atman Health, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Patient satisfaction	A patient satisfaction survey with questions similar to the Consumer Assessment of Healthcare Providers and Systems will be used.	6 months
Other	Provider satisfaction	A survey instrument will be developed and administered to assess provider satisfaction with having a remote team manage their patients.	6 months
Other	Mean time required per patient for provider	Cumulative time in minutes for all interactions, including documentation.	6 months
Other	Mean time required per patient for navigator	Cumulative time in minutes for all interactions, including documentation.	6 months
Other	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
Other	Resource utilization	Difference in resource utilization between intervention and usual care for different patient groups using claims data.	18 months
Primary	Difference in SBP change	Difference in mean change in systolic blood pressure (SBP)	6 months after enrollment
Secondary	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
Secondary	Difference in DBP change	Difference in mean change in diastolic blood pressure (DBP)	6 months after enrollment