Automated Feedback for High Blood Pressure

(AUTO 2 Trial)

YA
Overseen ByYaw Amofa Peprah, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether automated feedback and automatic transmission of blood pressure readings can help people manage high blood pressure more effectively. Participants will use a home blood pressure monitor and either manually enter results or allow an app to send them directly to their health records. The trial will compare these methods to determine which is most effective in controlling blood pressure over a year. Individuals with high blood pressure (140/90 mm Hg or higher) who receive care from a Northwestern Medicine doctor may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance blood pressure management for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this automated feedback and transmission method is safe for managing high blood pressure?

Research has shown that using automated feedback and remote blood pressure monitoring is generally safe. Studies have found that automatically sending blood pressure data to healthcare providers effectively lowers blood pressure and is well-received by patients. This method outperforms usual care in managing high blood pressure without adding extra risks.

Research indicates that sending patients messages about their blood pressure results helps them manage their condition. This approach encourages more accurate home tracking of blood pressure, aiding in better hypertension control.

When combined, automated feedback and remote monitoring remain effective and safe. Evidence from various studies supports their use in improving blood pressure control without significant side effects. Overall, these methods are considered safe options for managing high blood pressure at home.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage high blood pressure using technology. Unlike traditional methods where patients manually record and share their blood pressure data, this trial investigates automated systems that streamline the process. Participants might use an app that directly transmits their blood pressure readings to their electronic health records (EHR) or receive automated feedback through their EHR portal. This approach aims to enhance patient engagement and accuracy in monitoring, potentially leading to better blood pressure control and more personalized care.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will compare different methods of managing high blood pressure. Research has shown that automatically sending blood pressure readings from home, as tested in the "Automated Transmission of Remotely Monitored Blood Pressure" arm, can lower blood pressure more effectively than regular care. The "Automated Patient Feedback on Self Blood Pressure Monitoring" arm evaluates the impact of receiving automatic feedback on blood pressure readings, helping participants understand and manage their blood pressure more effectively. Additionally, the "Automated Transmission of Remotely Monitored Blood Pressure and Automated Feedback" arm combines these methods, potentially leading to better blood pressure control and providing more accurate information for doctors.12678

Who Is on the Research Team?

SD

Stephen D Persell, MD,MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-84 with high blood pressure that isn't well controlled, who get their hypertension care at Northwestern Medicine and have or are willing to set up a patient portal account.

Inclusion Criteria

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.
See 1 more

Exclusion Criteria

Known to have average home blood pressure or most recent home blood pressure value of <130/80 mm Hg.
Dementia
Nursing home resident
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a blood pressure monitor and either manually record or automatically transmit their blood pressure readings, with or without automated feedback

12 months

Follow-up

Participants are monitored for persistence of effects on blood pressure management

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Automated feedback about home blood pressure results
  • Automated Transmission of Remotely Measured Blood Pressure
  • Self report of home measured blood pressure via patient EHR portal

Trial Overview

The study compares sending patients automated feedback about their home blood pressure readings versus no feedback, and also looks at the difference between automatic transmission of these readings versus self-reporting them through an online portal.

How Is the Trial Designed?

4

Treatment groups

Active Control

Group I: Automated Transmission of Remotely Monitored Blood PressureActive Control1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention
Group III: Automated Patient Feedback on Self Blood Pressure MonitoringActive Control2 Interventions
Group IV: Automated Transmission of Remotely Monitored Blood Pressure and Automated FeedbackActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34106085/

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