HypertensionNCT06899750
E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control
A study testing E3 Multidisciplinary Team and E3 Self-Guided Hypertension Education Program in people with Hypertension, run by Rush University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- E3 Multidisciplinary Team and E3 Self-Guided Hypertension Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient has a smart phone (Android or iOS)
- Patient has an email
Who cannot join
- Organ transplant recipient
- On dialysis
- Patient is already participating in another remote hypertension monitoring program
- Patient is not interested in participating in the program
- Patient has already participated in the E3 Hypertension program or the E3 Diabetes program
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, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Kristen Pallok, MD, 312-942-6700, Kristen_N_Pallok@rush.edu
Elizabeth Legorreta, MSN, NP-C, 3129426700, Elizabeth_M_Legorreta@rush.edu
About this study
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.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death in the US as well as in Chicago. Risk factors for CVD include hypertension, diabetes, and lifestyle factors such as smoking, diet, and obesity. Among the critical social and structural determinants of cardiovascular health are food access, neighborhood safety, education, poverty, and chronic stress. Chicago and its surrounding region suffer from longstanding racial disparities in both social conditions and chronic disease burden, contributing to stark racial gaps in cardiometabolic disease mortality. Life expectancy is as high as 84 years on Chicago's North Side, but only 68 years on the West Side - a gap of 16 years.
Rush has collaborated with Novartis to "close the gap" in CVD inequities on Chicago's West Side by concentrating a critical mass of resources on community-centric approaches to wellness, prevention and management. Engage, Empower, Evaluate (E3) has been built on the foundation of Rush's mission to ensure that all patients and individuals at risk of developing CVD on Chicago's West Side receive the care they need, regardless of race/ethnicity, socioeconomic status, gender, or neighborhood, with the ultimate goal to reduce the CVD life expectancy gap for West Side residents by 50% by 2030. To do so, the study team coordinated clinical and community programming into a seamless health-promoting environment, tailored to the specific needs of the population, through remote monitoring and a multidisciplinary team composed of a nurse, social worker, and pharmacist.
The study team now proposes a trial of the E3 intervention, a remote hypertension monitoring, social care, medication adherence and behavioral lifestyle intervention to improve hypertension control among African American and Latinx patients attending primary care clinics at Rush University Medical Group locations with the eventual aim of closing the racial/ethnic disparity in hypertension control. The proposed feasibility trial will use a randomized-control, four-pronged approach to improve hypertension control. The intervention group will receive the following: 1) remote blood pressure monitoring, 2) a multidisciplinary team composed of nurse, pharmacist and social worker to address medical and social needs, 3) medication titration and adherence support, and 4) a culturally tailored hypertension self-management and diet education mobile phone application. The control group will receive an enhanced version of standard of care for hypertension through a home blood pressure cuff, and dietary and lifestyle educational materials tailored to hypertension self-management sent at timed intervals. The study team hypothesizes that the E3 Hypertension program participants will achieve a greater decrease in systolic blood pressure, and a greater percentage will have reduction of blood pressure below stage 2 hypertension (<140/90) in comparison to the control group receiving enhanced standard of care for hypertension.
- Conditions
- Hypertension
- Being tested
- E3 Multidisciplinary Team, E3 Self-Guided Hypertension Education Program
- Keywords
- hypertension, self-monitoring, social determinants of health, adherence
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E3 Multidisciplinary TeamBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension Team Based Group | Experimental | A multidisciplinary team composed of a pharmacist, social worker, and nurse coupled to a self-monitoring blood pressure phone app will provide hypertension monitoring, medication titration, diet and lifestyle education, and referrals for social needs. The team will interact with the patients predominantly via tele-health remotely for 6 months. Receives: Behavioral: E3 Multidisciplinary Team |
| Hypertension Self-Guided Group | Active comparator | A research assistant ensures patients in the self-guided group have a home blood pressure monitor on enrollment and will call patients at 3 and 6 months to ensure the blood pressure monitor is functioning correctly and to remind patients to check their blood pressure and follow-up with their primary care doctors. Patients will continue with standard clinical care for hypertension in addition to receiving timed, mailed educational materials on hypertension, remote monitoring, diet and lifestyle recommendations for 6 months. Receives: Behavioral: E3 Self-Guided Hypertension Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Hypertension control at 9 months
Percentage of participants with hypertension control (BP< 140/90) at 9 months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start10 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Kristen Pallok, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899750
- Sponsor's protocol ID
- 24100803
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared, however aggregate patient data may be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control
- ClinicalTrials.gov ID
- NCT06899750
- Acronym / sponsor ID
- 24100803
- Conditions
- Hypertension
- Keywords
- hypertension, self-monitoring, social determinants of health, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death in the US as well as in Chicago. Risk factors for CVD include hypertension, diabetes, and lifestyle factors such as smoking, diet, and obesity. Among the critical social and structural determinants of cardiovascular health are food access, neighborhood safety, education, poverty, and chronic stress. Chicago and its surrounding region suffer from longstanding racial disparities in both social conditions and chronic disease burden, contributing to stark racial gaps in cardiometabolic disease mortality. Life expectancy is as high as 84 years on Chicago's North Side, but only 68 years on the West Side - a gap of 16 years.
Rush has collaborated with Novartis to "close the gap" in CVD inequities on Chicago's West Side by concentrating a critical mass of resources on community-centric approaches to wellness, prevention and management. Engage, Empower, Evaluate (E3) has been built on the foundation of Rush's mission to ensure that all patients and individuals at risk of developing CVD on Chicago's West Side receive the care they need, regardless of race/ethnicity, socioeconomic status, gender, or neighborhood, with the ultimate goal to reduce the CVD life expectancy gap for West Side residents by 50% by 2030. To do so, the study team coordinated clinical and community programming into a seamless health-promoting environment, tailored to the specific needs of the population, through remote monitoring and a multidisciplinary team composed of a nurse, social worker, and pharmacist.
The study team now proposes a trial of the E3 intervention, a remote hypertension monitoring, social care, medication adherence and behavioral lifestyle intervention to improve hypertension control among African American and Latinx patients attending primary care clinics at Rush University Medical Group locations with the eventual aim of closing the racial/ethnic disparity in hypertension control. The proposed feasibility trial will use a randomized-control, four-pronged approach to improve hypertension control. The intervention group will receive the following: 1) remote blood pressure monitoring, 2) a multidisciplinary team composed of nurse, pharmacist and social worker to address medical and social needs, 3) medication titration and adherence support, and 4) a culturally tailored hypertension self-management and diet education mobile phone application. The control group will receive an enhanced version of standard of care for hypertension through a home blood pressure cuff, and dietary and lifestyle educational materials tailored to hypertension self-management sent at timed intervals. The study team hypothesizes that the E3 Hypertension program participants will achieve a greater decrease in systolic blood pressure, and a greater percentage will have reduction of blood pressure below stage 2 hypertension (<140/90) in comparison to the control group receiving enhanced standard of care for hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension Team Based Group | Experimental | Behavioral: E3 Multidisciplinary TeamA multidisciplinary team composed of a pharmacist, social worker, and nurse coupled to a self-monitoring blood pressure phone app will provide hypertension monitoring, medication titration, diet and lifestyle education, and referrals for social needs. The team will interact with the patients predominantly via tele-health remotely for 6 months. |
| Hypertension Self-Guided Group | Active comparator | Behavioral: E3 Self-Guided Hypertension Education ProgramA research assistant ensures patients in the self-guided group have a home blood pressure monitor on enrollment and will call patients at 3 and 6 months to ensure the blood pressure monitor is functioning correctly and to remind patients to check their blood pressure and follow-up with their primary care doctors. Patients will continue with standard clinical care for hypertension in addition to receiving timed, mailed educational materials on hypertension, remote monitoring, diet and lifestyle recommendations for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Patient has a smart phone (Android or iOS)
Key exclusion criteria (5 listed)
- Organ transplant recipient
- On dialysis
- Patient is already participating in another remote hypertension monitoring program
- Patient is not interested in participating in the program
- Patient has already participated in the E3 Hypertension program or the E3 Diabetes program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E3 Multidisciplinary TeamThe 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. | Behavioural | Hypertension Team Based Group |
| E3 Self-Guided Hypertension Education ProgramPatients 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. | Behavioural | Hypertension Self-Guided Group |
Primary outcome
Systolic blood pressure change at 6 months
Time frame: 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.
1 secondary outcome
Hypertension control at 9 months
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared, however aggregate patient data may be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Pallok, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E3 Multidisciplinary Team and E3 Self-Guided Hypertension Education Program in people with Hypertension, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Pallok, MD (13129426700, Kristen_N_Pallok@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure change at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.