Health TrialsbyHealthPanel

Penn Medicine Healthy Heart

ConditionsHypertensionHyperlipidemias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorUniversity of Pennsylvania

About this trial

To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll a program that will be evaluated in a clinical trial that is focused on changing patient behavior and powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest Philadelphia and Lancaster.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

On the Penn Medicine Primary Care Service Line registry

Last 2 Blood Pressure readings with Systolic Blood Pressure >=140 from any outpatient encounter in the last 12 months AND

ASCVD dx OR ASCVD risk score ≥10% OR Diabetes dx OR A1c ≥6.5 in last year OR Diabetes registry OR Last LDL ≥190 in past five years AND

Not on a statinor PCSK9, Inclisiran OR on a Low-intensity/moderate-intensity statin) with LDL >100

Disqualifiers

Patients on PCSK9 inhibitors

Documented statin allergy/ or intolerance in the EMR

Pregnancy

Breast feeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Penn Med Healthy Heart Program

    Behavioral

    Patients randomized to the intervention arm will be assigned a Patient Navigator (Clinical Research Coordinators, with support from Nurse Practitioners and a Medical Director) who will conduct an initial assessment with the patient to determine their main barriers to improving blood pressure and cholesterol control. The Patient Navigators will provide the patient with a home blood pressure cuff for remote monitoring, support from Way to Health text message reminders, referrals to established Penn Medicine smoking cessation programs, and referrals to nutrition and social workers as applicable. The Patient Navigators will help move the patients through four modules: Blood Pressure, Food Insecurity/Nutrition Screening, Statins, and Smoking Cessation. These modules provide patients with the chance to work on blood pressure, cholesterol control, access nutrition resources, and smoking cessation simultaneously or sequentially.

Treatment groups

1,980 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: Penn Med Healthy Heart ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in mean Systolic Blood Pressure (SBP)

Whether mean SBP is improved among those assigned to intervention vs those assigned to control

Time frame
6-month period
2

Difference in mean LDL-c

Whether mean LDL-c is improved among those assigned to intervention vs those assigned to control

Time frame
6-month period

Secondary outcomes

1

Engagement in the BP intervention

Engagement in the BP intervention as measured by number of participants who agree to receive blood pressure monitor

Time frame
6-month period
2

Difference in Diastolic Blood Pressure (DBP)

Whether mean DBP is improved among those assigned to intervention vs those assigned to control Whether mean SBP is improved among those assigned to intervention vs those assigned to control

Time frame
6-month period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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