Familial HypercholesterolemiaNCT05430191
Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia
An observational study of Familial Hypercholesterolemia, run by Northwestern University at 1 site in United States.
Trial summary
Design, refine, and pilot the two implementation approaches using behavioral economics and then seek further feedback prior to the proposed clinical trial, consistent with these recommendations. Aim 1. 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
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Aim 1 (Interviews). We will conduct interviews with 15 patients with high cholesterol and/or FH to understand barriers and facilitators to cascade screening. 17 clinicians are being interviewed through our sister protocol in an effort to reduce interview burden on clinicians. Duration of participation will last the length of one qualitative interview. Aim 2 (Pilot Testing Strategies). Participants will include 20 patients with high cholesterol and/or FH. At least half will identify as racial and/or ethnic minorities (i.e., Black or African American, Asian), female, and/or have low income. Patients will be randomized to receive the Penn- or FHF-mediated strategy. Duration of participation will last up to 3 months for each participant.
Who may be able to join
- Patients with high cholesterol and/or FH (i.e., probands; Aim 1 Interviews, Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older with clinically diagnosed FH and/or high cholesterol who are treated within Penn Medicine.
- Family Members (Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older who have a family member who has been identified as a patient with high cholesterol and/or FH who is treated within Penn Medicine (i.e., family members of probands).
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Leveraging Behavioral Economics to Equitably Implement Cascade Screening in Individuals With Familial Hypercholesterolemia in Partnership With the Family Heart Foundation
Design, refine, and pilot the two implementation approaches using behavioral economics and then seek further feedback prior to the proposed clinical trial, consistent with these recommendations.
Aim 1. Co-design both implementation strategies using behavioral economics in partnership with the Family Heart Foundation and key partners from diverse backgrounds.
Aim 2. Pilot strategies with 20 patients with high cholesterol and/or with familial hypercholesterolemia (FH) to ascertain feasibility, acceptability, appropriateness.
Read the detailed description
Aim 1. Conduct interviews with patients with high cholesterol and/or FH and clinicians to identify common barriers and facilitators for individuals to engage in cascade screening. These activities will occur in the first 7 months and will serve as inputs into the design of the implementation strategies to ensure that strategies address determinants identified in the interviews.
Aim 2. To maximize success, pilot test the implementation strategies and the planned data collection approaches.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- 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 ScreeningOther
FH is a genetic condition that causes high LDL cholesterol starting at birth. 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 |
|---|---|---|
| Qualitative Interviews | Conduct 15 interviews with patients diagnosed with FH. Interviews will be 30-60 minutes in length and will focus on how individuals understand cascade screening, barriers to engagement including reasons why individuals do and do not share health information with family members, and preferred approaches to engaging family members, with a focus on acceptability, appropriateness, and feasibility of the planned implementation strategies. Interviewers will also attend to structural factors such as medical mistrust and experiences of racism in health care, and ask about preferences and logistics to incorporate preference into the future clinical trial design. | |
| Penn-mediated implementation strategy | The Penn-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patients would receive text messages and/or emails containing information about FH and cascade screening from Penn Medicine. This would include a request for the patient to identify first-degree biological relatives. They would be given a choice of either contacting their family members directly or sharing their contact information so someone from Penn Medicine can contact them. If the proband chooses to contact their family members, they receive educational information to share with them. Family members would be offered FH screening at no cost by blood lipid panel. Receives: Other: Cascade Screening | |
| Family Heart Foundation-mediated implementation strategy | The Family Heart Foundation (FHF)-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patient would be contacted by a FHF patient navigator. The patient navigator would ask to set up a time to talk to the patient to talk about options for contacting family members, introduce them to the services they can provide to the patient and/or family members and obtain some details about the patient's family. The patient would come up with a plan to either contact their family members directly or have the patient navigator contact them. Family members will be offered FH screening at no cost by blood lipid panel. The patient and/or family members will be able to contact the patient navigator at any time with questions. Receives: Other: Cascade Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening
We will learn about the perspectives on cascade screening from clinicians and patients with high cholesterol and/or FH (probands) via qualitative interview.
Measured: 1-time interview to last 1 hour
Aim 2 Mini-Pilot Outcome: Engagement
We define engagement as the number of patients with FH and/or high cholesterol (probands) who respond to at least one outreach attempt.
Measured: 3 months
Aim 2 Mini-Pilot Outcome: Reach
We define reach as the proportion of probands who have at least one family member who completes cascade screening.
Measured: 3 months
Aim 2 Mini-Pilot Outcome: Perspectives on implementation strategies
We will learn about the perspectives on the implementation strategies (health system-mediated, Family Heart Foundation-mediated) - including their perceived acceptability, appropriateness, and feasibility - of patients with high cholesterol and/or FH (probands) and family members via qualitative interview.
Measured: 1-time interview to last approximately 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start20 Jul 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Family Heart Foundation, University of Pennsylvania
- Responsible party
- Principal investigator, Rinad Beidas, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430191
- Sponsor's protocol ID
- 851061
- Status last verified
- Sep 2023
- First submitted
- 8 Jun 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Behavioral Economics to Equitably Implement Cascade Screening in Individuals With Familial Hypercholesterolemia in Partnership With the Family Heart Foundation
- ClinicalTrials.gov ID
- NCT05430191
- Acronym / sponsor ID
- 851061
- Conditions
- Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Family Heart Foundation, University of Pennsylvania
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Jun 2022 (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.
Design, refine, and pilot the two implementation approaches using behavioral economics and then seek further feedback prior to the proposed clinical trial, consistent with these recommendations.
Aim 1. Co-design both implementation strategies using behavioral economics in partnership with the Family Heart Foundation and key partners from diverse backgrounds.
Aim 2. Pilot strategies with 20 patients with high cholesterol and/or with familial hypercholesterolemia (FH) to ascertain feasibility, acceptability, appropriateness.
Detailed description
Aim 1. Conduct interviews with patients with high cholesterol and/or FH and clinicians to identify common barriers and facilitators for individuals to engage in cascade screening. These activities will occur in the first 7 months and will serve as inputs into the design of the implementation strategies to ensure that strategies address determinants identified in the interviews.
Aim 2. To maximize success, pilot test the implementation strategies and the planned data collection approaches.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interviews | – | –Conduct 15 interviews with patients diagnosed with FH. Interviews will be 30-60 minutes in length and will focus on how individuals understand cascade screening, barriers to engagement including reasons why individuals do and do not share health information with family members, and preferred approaches to engaging family members, with a focus on acceptability, appropriateness, and feasibility of the planned implementation strategies. Interviewers will also attend to structural factors such as medical mistrust and experiences of racism in health care, and ask about preferences and logistics to incorporate preference into the future clinical trial design. |
| Penn-mediated implementation strategy | – | Other: Cascade ScreeningThe Penn-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patients would receive text messages and/or emails containing information about FH and cascade screening from Penn Medicine. This would include a request for the patient to identify first-degree biological relatives. They would be given a choice of either contacting their family members directly or sharing their contact information so someone from Penn Medicine can contact them. If the proband chooses to contact their family members, they receive educational information to share with them. Family members would be offered FH screening at no cost by blood lipid panel. |
| Family Heart Foundation-mediated implementation strategy | – | Other: Cascade ScreeningThe Family Heart Foundation (FHF)-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patient would be contacted by a FHF patient navigator. The patient navigator would ask to set up a time to talk to the patient to talk about options for contacting family members, introduce them to the services they can provide to the patient and/or family members and obtain some details about the patient's family. The patient would come up with a plan to either contact their family members directly or have the patient navigator contact them. Family members will be offered FH screening at no cost by blood lipid panel. The patient and/or family members will be able to contact the patient navigator at any time with questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1 (Interviews). We will conduct interviews with 15 patients with high cholesterol and/or FH to understand barriers and facilitators to cascade screening. 17 clinicians are being interviewed through our sister protocol in an effort to reduce interview burden on clinicians. Duration of participation will last the length of one qualitative interview. Aim 2 (Pilot Testing Strategies). Participants will include 20 patients with high cholesterol and/or FH. At least half will identify as racial and/or ethnic minorities (i.e., Black or African American, Asian), female, and/or have low income. Patients will be randomized to receive the Penn- or FHF-mediated strategy. Duration of participation will last up to 3 months for each participant.
Key inclusion criteria (2 listed)
- Patients with high cholesterol and/or FH (i.e., probands; Aim 1 Interviews, Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older with clinically diagnosed FH and/or high cholesterol who are treated within Penn Medicine.
- Family Members (Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older who have a family member who has been identified as a patient with high cholesterol and/or FH who is treated within Penn Medicine (i.e., family members of probands).
Key exclusion criteria (1 listed)
- none
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 high LDL cholesterol starting at birth. 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. | Other | Family Heart Foundation-mediated implementation strategy, Penn-mediated implementation strategy |
Primary outcome
Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening
Time frame: 1-time interview to last 1 hour
We will learn about the perspectives on cascade screening from clinicians and patients with high cholesterol and/or FH (probands) via qualitative interview.
Aim 2 Mini-Pilot Outcome: Engagement
Time frame: 3 months
We define engagement as the number of patients with FH and/or high cholesterol (probands) who respond to at least one outreach attempt.
Aim 2 Mini-Pilot Outcome: Reach
Time frame: 3 months
We define reach as the proportion of probands who have at least one family member who completes cascade screening.
Aim 2 Mini-Pilot Outcome: Perspectives on implementation strategies
Time frame: 1-time interview to last approximately 15-30 minutes
We will learn about the perspectives on the implementation strategies (health system-mediated, Family Heart Foundation-mediated) - including their perceived acceptability, appropriateness, and feasibility - of patients with high cholesterol and/or FH (probands) and family members via qualitative interview.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening (time frame: 1-time interview to last 1 hour). The study lists 4 primary outcomes in all. 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 29 Sep 2023.