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Enrolling by invitation NCT07397260

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

No phase Interventional Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Hypertension (HTN). Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Systolic blood pressure at 12 months [Time frame: 12 months]
Secondary outcome measures (7)
  • Systolic blood pressure at 18 months [Time frame: 18 months]
  • Antihypertensive medication changes from baseline [Time frame: From baseline to 12 months and 18 months]
  • Antihypertensive medication classes prescribed, standardized count [Time frame: 12 months and 18 months]
  • Medication adherence (patient report, Domains of Subjective Extent of Nonadhernece) [Time frame: 12 months and 18 months]
  • Diastolic blood pressure [Time frame: 12 months and 18 months]
  • Blood pressure <130/80 mm Hg [Time frame: 12 months and 18 months]
  • Blood pressure <140/90 mm Hg [Time frame: 12 months and and 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University Feinberg School of Medicine — Chicago

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. PMID 29436308
  • Voils 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. PMID 31037593
  • Voils 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. PMID 22922431
  • Voils 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. PMID 36419584
  • American 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. PMID 23621969

Identifiers

NCT: NCT07397260 · STU00224615 · R01HL179919

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗