E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

This study aims to compare a multidisciplinary clinical hypertension and social needs intervention to enhanced standard of care for hypertension management in primary care clinics with regards to hypertension control outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years or older

African American and/or Latinx

Uncontrolled stage 2 hypertension, BP >/= 140/90

Patient is following with Rush primary care provider in eligible Rush primary care clinics

Disqualifiers

Organ transplant recipient

On dialysis

Patient is already participating in another remote hypertension monitoring program

Patient is not interested in participating in the program

Trial design

Design model

Parallel

Treatments tested in this trial

  • E3 Multidisciplinary Team

    Behavioral

    The E3 Multidisciplinary team is composed of a remote pharmacist, social worker, and nurse working together with patients via a remote monitoring, educational hypertension phone app to overcome barriers to hypertension control via behavioral change, medication adherence and titration, diet and lifestyle education and resource referrals for social needs.

  • E3 Self-Guided Hypertension Education Program

    Behavioral

    Patients will receive timed, mailed educational materials on hypertension self-monitoring, diet and lifestyle modifications to supplement usual clinic-based hypertension care with their primary care doctor. A research assistant will ensure patients have home blood pressure monitors on enrollment, and will remind patients to check their blood pressures and follow-up with their primary care doctors at 3 months and 6 months.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Hypertension Team Based GroupExperimental treatment 1 intervention
Group B: Hypertension Self-Guided GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Systolic blood pressure change at 6 months

Percentage of participants with a decrease in systolic blood pressure of at least 10mmHg between pre and post clinic-based blood pressure measurements.

Time frame
6 months

Secondary outcomes

1

Hypertension control at 9 months

Percentage of participants with hypertension control (BP\< 140/90) at 9 months

Time frame
9 months

Other outcomes

Sponsors and contacts

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Rush University Medical Center

Lead sponsor

Novartis Pharmaceuticals

Collaborator