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NCT05750667Enrolling by invitation

Penn Family Screening for Familial Hypercholesterolemia

Leveraging Behavioral Economics to Equitably Implement Cascade Screening in Individuals With Familial Hypercholesterolemia in Partnership With the FH Foundation (R33 Phase)

Source: ClinicalTrials.gov · Last updated 9 Feb 2026

Brief summary (registry, in English)

The goal of this clinical trial is to test two implementation strategies (automated health system \[Penn Medicine\]-mediated strategy vs. Family Heart Foundation-mediated strategy using a patient navigator) versus usual care to promote family cascade screening for familial hypercholesterolemia (FH) in Penn Medicine patients diagnosed with FH ("probands"). The main questions this study aims to answer are: (1) evaluating the effect of the three approaches on reach (proportion of probands who have at least one family member who completes screening), number of family members screened, number of family members diagnosed with FH, and proband LDL-C levels; and (2) identifying implementation strategy mechanisms focusing on health equity using mixed methods and oversampling populations that experience disparities. Participants (probands) in the active arms (health system \[Penn Medicine\]-mediated, Family Heart Foundation-mediated) will receive messaging that provides education about FH and provides instructions for participating in family cascade screening. A subset of probands will be invited to complete a qualitative interview about their experience receiving the implementation strategy. The research team will compare the active arms to Penn Medicine usual care for cascade screening to evaluate whether the active arms are more effective at promoting cascade screening than usual care.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
800 (estimated)
First submitted
15 Feb 2023
Start date
24 Jan 2023
Primary completion date
28 Feb 2027
Lead sponsor
Northwestern University
NCT number
NCT05750667

What you commit to

  • Study type: Interventional
  • Planned participants: 800
  • From 24 Jan 2023 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • People under age 18

Other

  • Do not have contact information for at least one living, first-degree biological relative
  • Do not have a cell phone with texting capabilities nor access to email

Who the study is looking for

  • Adults aged 18 years and older with clinically diagnosed FH who are treated within the Penn Medicine system
  • Have contact information for at least one living, first-degree biological relative
  • Have a cell phone with texting capabilities and/or access to email

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pennsylvania Perelman School of Medicine
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.