Familial HypercholesterolemiaNCT07919353
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
A study testing Cascade Screening in people with Familial Hypercholesterolemia, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test two implementation strategies (digital strategy vs. care navigator strategy) to promote family cascade screening for familial hypercholesterolemia (FH) in Penn Medicine patients diagnosed with FH ("probands"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Cascade Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 28 Feb 2028
- 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
- Current or recent Penn Medicine patient (i.e., had a visit with a Penn Medicine clinician in the past 2 years)
- Age 18 or older
- Clinically diagnosed FH
- At least one contact method available in the electronic health record
- Alive
Who cannot join
- Participated in a prior FH cascade screening study at Penn Medicine
- Does not positively confirm identity
- Unreachable by mail, phone, text, and email (i.e., all messages undeliverable)
- Those who self-report not having contact information for at least 1 living biological first-degree relative in the US and/or report that all eligible relatives have already completed cascade screening
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
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Daniel Rader, MD, (215) 573-4176, rader@pennmedicine.upenn.edu
About this study
Official title: Leveraging Behavioral Economics to Implement Cascade Screening in Individuals With Familial Hypercholesterolemia
The goal of this clinical trial is to test two implementation strategies (digital strategy vs. care navigator strategy) 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 approaches on reach (proportion of probands who have at least one family member who completes screening), number of family members screened, proband engagement with the study, and proband LDL-C levels; and (2) use mixed methods to identify implementation strategy mechanisms. Participants (probands) will receive messaging that provides education about FH and provides instructions for participating in family cascade screening. A subset of participants will be invited to complete a qualitative interview about their experience receiving the implementation strategy. The research team will compare the arms to evaluate their effectiveness at promoting cascade screening.
Read the detailed description
The study will test two patient-facing implementation strategies to increase reach of cascade screening with FH probands within Penn Medicine via a 2-arm hybrid type III effectiveness-implementation randomized controlled trial (RCT). This pragmatic RCT will test (a) a digital strategy using automated text messages and emails and (b) a care navigator strategy. Both strategies were designed using insights from behavioral economics.
Aim 1: Compare the effect of the study arms on implementation and effectiveness outcomes: reach (primary outcome), or proportion of probands who have at least one family member who completes screening; absolute number of family members screened; proband engagement with the study; and proband LDL-C levels.
Aim 2: Use mixed methods to identify implementation strategy mechanisms. Aim 2a: Conduct interviews to understand proband perspectives using the Consolidated Framework for Implementation Research. Aim 2b: Explore differential strategy effectiveness quantitatively and descriptively.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Cascade Screening
- Keywords
- implementation science, behavioral economics, cascade screening
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cascade ScreeningBehavioural
FH is a genetic condition that causes very high LDL cholesterol. When one individual with FH is diagnosed, it is important that biological family members are also screened, since there is a 50% chance that each first-degree relative will have also inherited FH. More distant relatives may also have inherited FH. This evidence-based process is known as cascade screening.
| Study group | Role | What they receive |
|---|---|---|
| Digital | Experimental | Probands receive automated text messages and/or emails from Penn Medicine containing information about FH and cascade screening and a request to share educational materials (provided by the study) with their relatives. All relatives will be offered FH screening at no cost. Probands will receive reminders to contact their relatives and behavioral economics-informed tips to encourage completion. Receives: Behavioral: Cascade Screening |
| Navigator | Experimental | A Penn Medicine-based care navigator will reach out to probands. 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 the relative join a call with the proband and navigator. Those who choose self-contact receive personalized coaching to address barriers and concerns. All relatives 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. Receives: Behavioral: Cascade Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
The proportion of eligible probands (i.e., Penn Medicine patients diagnosed with familial hypercholesterolemia or "FH") who have at least one relative who is screened for FH within 6 months of the proband's randomization date. We define 'completed screening' as (a) relatives sharing lipid panel results and completing a results consultation call with a study clinician. This information is documented by the study clinician during the call in REDCap; or (b) proband self-report of their relatives' completion of screening for FH.
Measured: Collected from proband randomization date through six months post-randomization
Secondary outcomes (3)
Absolute number of family members who are screened for FH as a result of cascade screening
The number of relatives who complete screening, collected via the same approaches as we are using for our primary outcome of reach (i.e., as described above)
Measured: Collected from proband randomization date through six months post-randomization
Proband engagement
The proportion of probands who respond to at least one outreach attempt at any point after positive identity confirmation
Measured: Collected from proband randomization date through six months post-randomization
Proband LDL-C
Proband LDL-C on a lipid panel completed between 11 and 13 months after proband randomization, as extracted from the electronic health record
Measured: 11-13 months post-proband randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Probands will be randomized 1:1 to the two implementation strategy arms.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Rinad Beidas, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919353
- Sponsor's protocol ID
- 20-1273
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Behavioral Economics to Implement Cascade Screening in Individuals With Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT07919353
- Acronym / sponsor ID
- 20-1273
- Conditions
- Familial Hypercholesterolemia
- Keywords
- implementation science, behavioral economics, cascade screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
The goal of this clinical trial is to test two implementation strategies (digital strategy vs. care navigator strategy) 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 approaches on reach (proportion of probands who have at least one family member who completes screening), number of family members screened, proband engagement with the study, and proband LDL-C levels; and (2) use mixed methods to identify implementation strategy mechanisms. Participants (probands) will receive messaging that provides education about FH and provides instructions for participating in family cascade screening. A subset of participants will be invited to complete a qualitative interview about their experience receiving the implementation strategy. The research team will compare the arms to evaluate their effectiveness at promoting cascade screening.
Detailed description
The study will test two patient-facing implementation strategies to increase reach of cascade screening with FH probands within Penn Medicine via a 2-arm hybrid type III effectiveness-implementation randomized controlled trial (RCT). This pragmatic RCT will test (a) a digital strategy using automated text messages and emails and (b) a care navigator strategy. Both strategies were designed using insights from behavioral economics.
Aim 1: Compare the effect of the study arms on implementation and effectiveness outcomes: reach (primary outcome), or proportion of probands who have at least one family member who completes screening; absolute number of family members screened; proband engagement with the study; and proband LDL-C levels.
Aim 2: Use mixed methods to identify implementation strategy mechanisms. Aim 2a: Conduct interviews to understand proband perspectives using the Consolidated Framework for Implementation Research. Aim 2b: Explore differential strategy effectiveness quantitatively and descriptively.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Probands will be randomized 1:1 to the two implementation strategy arms.
| Arm | Type | Receives |
|---|---|---|
| Digital | Experimental | Behavioral: Cascade ScreeningProbands receive automated text messages and/or emails from Penn Medicine containing information about FH and cascade screening and a request to share educational materials (provided by the study) with their relatives. All relatives will be offered FH screening at no cost. Probands will receive reminders to contact their relatives and behavioral economics-informed tips to encourage completion. |
| Navigator | Experimental | Behavioral: Cascade ScreeningA Penn Medicine-based care navigator will reach out to probands. 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 the relative join a call with the proband and navigator. Those who choose self-contact receive personalized coaching to address barriers and concerns. All relatives 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current or recent Penn Medicine patient (i.e., had a visit with a Penn Medicine clinician in the past 2 years)
- Age 18 or older
- Clinically diagnosed FH
- At least one contact method available in the electronic health record
- Alive
Key exclusion criteria (4 listed)
- Participated in a prior FH cascade screening study at Penn Medicine
- Does not positively confirm identity
- Unreachable by mail, phone, text, and email (i.e., all messages undeliverable)
- Those who self-report not having contact information for at least 1 living biological first-degree relative in the US and/or report that all eligible relatives have already completed cascade screening
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 |
|---|---|---|
| Cascade ScreeningFH is a genetic condition that causes very high LDL cholesterol. When one individual with FH is diagnosed, it is important that biological family members are also screened, since there is a 50% chance that each first-degree relative will have also inherited FH. More distant relatives may also have inherited FH. This evidence-based process is known as cascade screening. | Behavioural | Digital, Navigator |
Primary outcome
Reach
Time frame: Collected from proband randomization date through six months post-randomization
The proportion of eligible probands (i.e., Penn Medicine patients diagnosed with familial hypercholesterolemia or "FH") who have at least one relative who is screened for FH within 6 months of the proband's randomization date. We define 'completed screening' as (a) relatives sharing lipid panel results and completing a results consultation call with a study clinician. This information is documented by the study clinician during the call in REDCap; or (b) proband self-report of their relatives' completion of screening for FH.
3 secondary outcomes
Absolute number of family members who are screened for FH as a result of cascade screening
Time frame: Collected from proband randomization date through six months post-randomization
Proband engagement
Time frame: Collected from proband randomization date through six months post-randomization
Proband LDL-C
Time frame: 11-13 months post-proband randomization
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Familial Hypercholesterolemia
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An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
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Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
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Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cascade Screening in people with Familial Hypercholesterolemia, run by Northwestern University 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 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 Rinad S Beidas, PhD (312-503-0546, rinad.beidas@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Collected from proband randomization date through six months post-randomization). 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 5 Nov 2026.