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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-time collection at 12 months post-randomization
Awards & highlights
NHLBI-R33 Trial 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.Check my eligibility
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.See study design
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.
NHLBI-R33 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reach
Secondary outcome measures
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
NHLBI-R33 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).
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Who is running the clinical trial?
Family Heart FoundationUNKNOWN
2 Previous Clinical Trials
102 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
916,431 Total Patients Enrolled
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,879,288 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Penn Medicine (health system)-mediated
- Group 3: Family Heart Foundation-mediated
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being enrolled for this research endeavor?
"Clinicaltrials.gov reflects that this medical trial, which initially launched on January 24th 2023 and was last updated on February 27th 2023, is not accepting new patients. However there are 69 alternative studies recruiting at the present moment."
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