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Clinical Trial NCT07397260 (AUTO 2) for Hypertension (HTN) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Northwestern UniversityAutomatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial 1,304 Remote
Clinical Trial NCT07397260 (AUTO 2) is an interventional study for Hypertension (HTN) and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 1,304 participants. Led by Northwestern University, this study is expected to complete by 1 November 2028. The latest data from ClinicalTrials.gov was last updated on 9 February 2026.
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 w...Show More
Official Title
Effects of Manually Recorded or Automatically Transmitted Home Blood Pressures With or Without Automated Patient Feedback on Hypertension Care
Conditions
Hypertension (HTN)Publications
Scientific articles and research papers published about this clinical trial:- Liu L, Shih YCT, Strawderman RL, Zhang DW, Johnson BA, Chai HT. Statistical Analysis of Zero-Inflated Nonnegative Continuous Data: A Review. Stat Sci. 2019;34(2):253-279
- HealthMeasures. PROMIS Scale v1.2 - Global Health. 2024. Available at https://www.healthmeasures.net/index.php?option=com_instruments&view=measure&id=778&Itemid=9...
Other Study IDs
- AUTO 2
- STU00224615
- R01HL179919 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-02-09
Completion Date (Estimated)
2028-11
Enrollment (Estimated)
1,304
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Hypertension
Remote Patient Monitoring
RPM
Automated transmission
Home blood pressure
Hypertension Care
Remote Patient Monitoring
RPM
Automated transmission
Home blood pressure
Hypertension Care
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Factorial
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorEnhanced Usual Care Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. | 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 ComparatorAutomated Transmission of Remotely Monitored Blood Pressure Participants receive a blood pressure monitor and an application to directly transmit measurements to their EHR record. | 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 ComparatorAutomated 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. | 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. 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 ComparatorAutomated 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. | 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. 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Systolic blood pressure at 12 months | 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | |
Blood pressure <130/80 mm Hg | 12 months and 18 months | |
Blood pressure <140/90 mm Hg | 12 months and and 18 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
Northwestern UniversityNational Heart, Lung, and Blood Institute (NHLBI)747 active studies to exploreStudy Responsible Party
Stephen Persell, MD, MPH, Principal Investigator, Professor of Medicine, Northwestern University
Study Central Contact
Contact: Yaw Amofa Peprah, MPH, 3125032753, [email protected]
No location data.