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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07397260
Acronym
AUTO 2
Enrollment
1304
Registered
2026-02-09
Start date
2026-05-04
Completion date
2028-11-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension (HTN)

Keywords

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

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.

Interventions

OTHERSelf 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.

OTHERAutomated 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.

OTHERAutomated 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.

Sponsors

Northwestern University
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Systolic blood pressure at 12 months12 months

Secondary

MeasureTime frame
Systolic blood pressure at 18 months18 months
Antihypertensive medication changes from baselineFrom baseline to 12 months and 18 months
Antihypertensive medication classes prescribed, standardized count12 months and 18 months
Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece)12 months and 18 months
Diastolic blood pressure12 months and 18 months
Blood pressure <130/80 mm Hg12 months and 18 months
Blood pressure <140/90 mm Hg12 months and and 18 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStephen D Persell, MD,MPH

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026