Automatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial

NCT07397260 | Enrolling By Invitation

• 2 other identifiers: STU00224615R01HL179919
• Study Type: interventional
• Target: 1,304
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of automatically-generated medical advice to patients about to their home blood pressure monitoring results sent through patient portal messages compared to no automated advice and the effectiveness of automated transmission of remotely-obtained blood pressure values compared to self-reported values on systolic blood pressure at 1-year follow up in patients with uncontrolled hypertension whose physicians or advance practice providers provide primary care at Northwestern Medicine. Persistence of effects through 18 months will also be assessed.

Conditions

Hypertension (HTN)

Keywords

Hypertension; Remote Patient Monitoring; RPM; Automated transmission; Home blood pressure; Hypertension Care

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure at 12 months

  12 months

Secondary Outcomes (7)

• Systolic blood pressure at 18 months

  18 months

• Antihypertensive medication changes from baseline

  From baseline to 12 months and 18 months

• Antihypertensive medication classes prescribed, standardized count

  12 months and 18 months

• Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece)

  12 months and 18 months

• Diastolic blood pressure

  12 months and 18 months

Other Outcomes (5)

• Patient engagement (Consumer Health Activation Index)

  12 months and 18 months

• Quality of Life (PROMIS® Scale v1.2 -Global Health)

  12 months and 18 months

• Office encounters count

  From baseline to 12 months and 18 months

Study Arms (4)

Enhanced Usual Care

ACTIVE COMPARATOR

Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal.

Other: Self report of home measured blood pressure via patient EHR portal

Automated Transmission of Remotely Monitored Blood Pressure

ACTIVE COMPARATOR

Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record.

Other: Automated Transmission of Remotely Measured Blood Pressure

Automated Patient Feedback on Self Blood Pressure Monitoring

ACTIVE COMPARATOR

Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. Participants receive messages through the EHR patient portal about their home blood pressure results.

Other: Self report of home measured blood pressure via patient EHR portal; Other: Automated feedback about home blood pressure results

Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback

ACTIVE COMPARATOR

Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. Participants receive messages through the EHR patient portal about their home blood pressure results.

Other: Automated feedback about home blood pressure results; Other: Automated Transmission of Remotely Measured Blood Pressure

Interventions

Self report of home measured blood pressure via patient EHR portal OTHER

Participants will be provided with a home blood pressure monitor and method to use the EHR portal to enter home collected blood pressures into the EHR.

Automated Patient Feedback on Self Blood Pressure Monitoring; Enhanced Usual Care

Automated Transmission of Remotely Measured Blood Pressure OTHER

Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record.

Automated Transmission of Remotely Monitored Blood Pressure; Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback

Automated feedback about home blood pressure results OTHER

Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated.

Automated Patient Feedback on Self Blood Pressure Monitoring; Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-84 years at enrollment date
• Receives hypertension care primarily from a participating clinician
• Blood pressure on the two most recent days when ambulatory clinic blood pressure was obtained prior to patient identification to was ≥140 mm Hg systolic and/or ≥90 diastolic or last ambulatory clinic blood pressure was ≥150 mm Hg systolic and/or ≥95 diastolic
• Currently has or is willing to obtain a patient portal account from NM.

You may not qualify if:

• Dementia,
• Nursing home resident,
• Stage 5 chronic kidney disease or renal replacement therapy,
• Pregnancy,
• Receiving hospice,
• Not planning to continue to receive hypertension care from NM clinician for the next year,
• Planning to move from the region in the next year,
• Planning to change clinician treating their hypertension in the next year,
• Medical or psychological reason they cannot perform home blood pressure monitoring.
• Known to have average home blood pressure or most recent home blood pressure value of \<130/80 mm Hg.
• Primary care physicians and clinicians not willing for their patients to participate in study
• Planning to depart NM within the next year
• Not willing to receive patients' out-of-office blood pressure data

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephen D Persell, MD,MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)