Hypertension (HTN)AUTO 2NCT07397260
Automatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial
A study testing Self report of home measured blood pressure via patient EHR portal, Automated feedback about home blood pressure results and Automated Transmission of Remotely Measured Blood Pressure in people with Hypertension (HTN), run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Self report of home measured blood pressure via patient EHR portal, Automated feedback about home blood pressure results and Automated Transmission of Remotely Measured Blood Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,304 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: 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.
- Conditions
- Hypertension (HTN)
- Being tested
- Self report of home measured blood pressure via patient EHR portal, Automated feedback about home blood pressure results, Automated Transmission of Remotely Measured Blood Pressure
- Keywords
- Hypertension, Remote Patient Monitoring, RPM, Automated transmission, Home blood pressure, Hypertension Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self report of home measured blood pressure via patient EHR portalOther
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 resultsOther
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 PressureOther
Participants will be provided with a blood pressure monitor and application to automatically transmit home blood pressures to their EHR record.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | Participants receive a blood pressure monitor and are encouraged to enter blood pressure results into their EHR patient portal. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Automated feedback about home blood pressure results; Other: Automated Transmission of Remotely Measured Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure at 12 months
Measured: 12 months
Secondary outcomes (7)
Systolic blood pressure at 18 months
Measured: 18 months
Antihypertensive medication changes from baseline
Measured: From baseline to 12 months and 18 months
Antihypertensive medication classes prescribed, standardized count
Measured: 12 months and 18 months
Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece)
Measured: 12 months and 18 months
Diastolic blood pressure
Measured: 12 months and 18 months
Blood pressure <130/80 mm Hg
Measured: 12 months and 18 months
Blood pressure <140/90 mm Hg
Measured: 12 months and and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start4 May 2026
- Primary completionApr 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Stephen Persell, MD, MPH, Northwestern University
- Investigators
- Stephen D Persell, MD,MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397260
- Sponsor's protocol ID
- STU00224615
- Other IDs
- R01HL179919
- Acronym
- AUTO 2
- Status last verified
- May 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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=992.
Wolf MS, Smith SG, Pandit AU, Condon DM, Curtis LM, Griffith J, O'Conor R, Rush S, Bailey SC, Kaplan G, Haufle V, Martin D. Development and Validation of the Consumer Health Activation Index. Med Decis Making. 2018 Apr;38(3):334-343. doi: 10.1177/0272989X17753392. Epub 2018 Feb 13.
PubMed 29436308Voils CI, King HA, Thorpe CT, Blalock DV, Kronish IM, Reeve BB, Boatright C, Gellad ZF. Content Validity and Reliability of a Self-Report Measure of Medication Nonadherence in Hepatitis C Treatment. Dig Dis Sci. 2019 Oct;64(10):2784-2797. doi: 10.1007/s10620-019-05621-7. Epub 2019 Apr 29.
PubMed 31037593Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121.
PubMed 22922431Voils CI, Gavin KL, Thorpe CT, Pabich SK, Reeve BB, Mian GJ, Faacks A, Kronish IM. Validating a Self-Reported Medication Nonadherence Measure in the Context of Multiple Chronic Diseases and Routes of Medication Administration Among Patients with Type 2 Diabetes. Patient Prefer Adherence. 2022 Nov 17;16:3119-3130. doi: 10.2147/PPA.S382885. eCollection 2022.
PubMed 36419584American Heart Association. Available at https://www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home. 2024.
Kronish IM, Ye S. Adherence to cardiovascular medications: lessons learned and future directions. Prog Cardiovasc Dis. 2013 May-Jun;55(6):590-600. doi: 10.1016/j.pcad.2013.02.001. Epub 2013 Mar 23.
PubMed 23621969Peh KQE, Kwan YH, Goh H, Ramchandani H, Phang JK, Lim ZY, Loh DHF, Ostbye T, Blalock DV, Yoon S, Bosworth HB, Low LL, Thumboo J. An Adaptable Framework for Factors Contributing to Medication Adherence: Results from a Systematic Review of 102 Conceptual Frameworks. J Gen Intern Med. 2021 Sep;36(9):2784-2795. doi: 10.1007/s11606-021-06648-1. Epub 2021 Mar 3.
PubMed 33660211AlGhurair SA, Hughes CA, Simpson SH, Guirguis LM. A systematic review of patient self-reported barriers of adherence to antihypertensive medications using the world health organization multidimensional adherence model. J Clin Hypertens (Greenwich). 2012 Dec;14(12):877-86. doi: 10.1111/j.1751-7176.2012.00699.x. Epub 2012 Aug 20.
PubMed 23205755Oliveria SA, Lapuerta P, McCarthy BD, L'Italien GJ, Berlowitz DR, Asch SM. Physician-related barriers to the effective management of uncontrolled hypertension. Arch Intern Med. 2002 Feb 25;162(4):413-20. doi: 10.1001/archinte.162.4.413.
PubMed 11863473Rose AJ, Shimada SL, Rothendler JA, Reisman JI, Glassman PA, Berlowitz DR, Kressin NR. The accuracy of clinician perceptions of "usual" blood pressure control. J Gen Intern Med. 2008 Feb;23(2):180-3. doi: 10.1007/s11606-007-0464-1. Epub 2007 Nov 28.
PubMed 18043980Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension. 2022 Jan;79(1):e1-e14. doi: 10.1161/HYP.0000000000000203. Epub 2021 Oct 7.
PubMed 34615363Kerr EA, Zikmund-Fisher BJ, Klamerus ML, Subramanian U, Hogan MM, Hofer TP. The role of clinical uncertainty in treatment decisions for diabetic patients with uncontrolled blood pressure. Ann Intern Med. 2008 May 20;148(10):717-27. doi: 10.7326/0003-4819-148-10-200805200-00004.
PubMed 18490685Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.
PubMed 36116516