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Cascade Screening for High Cholesterol (NHLBI-R33 Trial)

N/A

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

People under age 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one-time collection at 12 months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial will test 2 approaches to help families of those with Familial Hypercholesterolemia (FH) get tested and treated. It will compare the effectiveness of the approaches to usual care. The goal is to promote screening and health equity.

Who is the study for?

This trial is for adults over 18 with familial hypercholesterolemia (FH) treated at Penn Medicine. They must have a cell phone or email and contact info for at least one living first-degree relative. It's not for those under 18 without these communication tools or family contacts.

What is being tested?

The study tests two strategies to encourage family screening for FH against usual care: an automated health system approach and a patient navigator-led strategy by the Family Heart Foundation. It measures how many relatives get screened, diagnosed, and effects on proband LDL-C levels.

What are the potential side effects?

Since this trial involves non-medical interventions like education and messaging about FH, there are no direct medical side effects from treatments as it doesn't involve drugs or medical procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected from proband randomization date through six months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected from proband randomization date through six months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected from proband randomization date through six months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reach

Secondary study objectives

Absolute number of family members who are newly diagnosed with FH as a result of cascade screening

Absolute number of family members who are screened for FH as a result of cascade screening

LDL-C in probands

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Penn Medicine (health system)-mediatedExperimental Treatment1 Intervention

Probands receive automated text messages and/or emails through the Way to Health (WTH) platform containing information about FH and cascade screening from Penn Medicine, and a request to identify first-degree biological relatives. Probands choose whether to contact relatives themselves or share contact information so that automated text messages and/or emails can be sent by Penn Medicine to relatives directly via WTH. If probands opt to contact relatives themselves (self-contact), they receive tips on how to do this effectively. If probands opt for Penn Medicine to contact their relatives (direct contact), relatives receive information via WTH about FH and instructions for screening. All relatives (regardless of whether they were contacted via self-contact and direct contact) will be offered FH screening at no cost. If a proband's initial choice of outreach is not successful, they will have the option of initiating the alternate outreach approach (direct or self-contact).

Group II: Family Heart Foundation-mediatedExperimental Treatment1 Intervention

After using WTH to conduct an identity screen and giving probands an option to opt-out of having their information shared with Family Heart Foundation (FHF), FHF reaches out directly to probands via an FHF-employed navigator. During an initial call, the navigator introduces the proband to navigation services, conducts a social history, and initiates a plan for contacting relatives. Probands choose whether to contact relatives themselves (self-contact) or have FHF contact relatives directly (direct contact). Those who choose self-contact receive personalized coaching to address barriers and concerns. For direct contact relatives, FHF will call these relatives directly. All relatives (regardless of whether they were contacted via self-contact and direct contact) will be offered FH screening at no cost. If a proband's initial choice of outreach is not successful, they will have the option of initiating the alternate outreach approach (direct or self-contact).

Group III: Usual CareActive Control1 Intervention

Probands randomized to this arm will not receive any contact from the research team or Family Heart Foundation regarding cascade screening (i.e., no intervention).

0 / 1Eligibility criteria met