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

May 11, 2026 updated by: Stephen Persell, MD, MPH, Northwestern University

Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

CLINICIAN PARTICIPANT INCLUSION Physician, advanced practice nurse or physician assistant working at a Northwestern Medicine ambulatory primary care site that cares for adults with hypertension (family medicine, internal medicine, medicine/pediatrics, and ambulatory geriatrics sites).

CLINICIAN PARTICIPANT EXCLUSION

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Usual Care
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
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.
Active Comparator: Automated Transmission of Remotely Monitored Blood Pressure
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
Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record.
Active Comparator: Automated Patient Feedback on Self Blood Pressure Monitoring
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
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.
Other: Automated feedback about home blood pressure results
Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated.
Active Comparator: Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback
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 Transmission of Remotely Measured Blood Pressure
Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record.
Other: Automated feedback about home blood pressure results
Patients will received periodic messages about the results of their home blood pressure monitoring with suggestions to consult with clinical care team when indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure at 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure at 18 months
Time Frame: 18 months
18 months
Antihypertensive medication changes from baseline
Time Frame: From baseline to 12 months and 18 months
From baseline to 12 months and 18 months
Antihypertensive medication classes prescribed, standardized count
Time Frame: 12 months and 18 months
12 months and 18 months
Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece)
Time Frame: 12 months and 18 months
12 months and 18 months
Diastolic blood pressure
Time Frame: 12 months and 18 months
12 months and 18 months
Blood pressure <130/80 mm Hg
Time Frame: 12 months and 18 months
12 months and 18 months
Blood pressure <140/90 mm Hg
Time Frame: 12 months and and 18 months
12 months and and 18 months

Other Outcome Measures

Outcome Measure
Time Frame
Patient engagement (Consumer Health Activation Index)
Time Frame: 12 months and 18 months
12 months and 18 months
Quality of Life (PROMIS® Scale v1.2 -Global Health)
Time Frame: 12 months and 18 months
12 months and 18 months
Office encounters count
Time Frame: From baseline to 12 months and 18 months
From baseline to 12 months and 18 months
Portal messages count
Time Frame: From baseline to 12 months and 18 months
From baseline to 12 months and 18 months
Telephone encounters count at 1 year and 18 months
Time Frame: From baseline to 12 months and 18 months
From baseline to 12 months and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Stephen D Persell, MD,MPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00224615
  • R01HL179919 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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