What side effects are associated with this type of intervention?

Common treatments for high cholesterol include statins, ezetimibe, and PCSK9 inhibitors. Statins are generally well-tolerated but can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Ezetimibe is usually well-tolerated but may cause gastrointestinal symptoms and, less commonly, muscle pain. PCSK9 inhibitors, such as alirocumab, are also well-tolerated but can cause injection site reactions, flu-like symptoms, and, rarely, neurocognitive issues. These side effects are important to discuss with a healthcare provider to ensure optimal management and adherence to therapy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of high cholesterol, including statins (e.g., simvastatin, rosuvastatin), ezetimibe, and PCSK9 inhibitors (e.g., alirocumab, evolocumab). Statins are often the first line of treatment due to their effectiveness in lowering LDL-C levels. Ezetimibe can be added to statin therapy for additional LDL-C reduction. PCSK9 inhibitors are used in patients who require further LDL-C lowering despite maximal statin and ezetimibe therapy. These treatments have been shown to significantly reduce cardiovascular events and are part of the multifactorial approach to managing high cholesterol.

What other types of research exist?

Promising alternatives to Motivational Interviewing for high cholesterol patients include: 1) Digital health interventions such as mobile apps and telehealth platforms that provide personalized feedback and support. 2) Proactive telephone counseling, which has shown efficacy in smoking cessation and could be adapted for cholesterol management. 3) Text messaging programs that offer automated motivational messages and real-time support. These methods leverage technology to enhance patient engagement and adherence to treatment plans.

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Motivational Interviewing for High Cholesterol (ID-FH Trial)

Phase 3

Recruiting

Research Sponsored by Essentia Health

Eligibility Criteria Checklist

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

Must have

Patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL

Patients with existing clinical diagnosis or suspected FH

Must not have

Known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post enrollment

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to help patients with suspected Familial Hypercholesterolemia (FH) by using motivational interviews. These interviews educate patients about their health risks and encourage them to inform their family members. The goal is to improve disease management and early detection in relatives.

Who is the study for?

This trial is for people aged 2-75 in Minnesota, Wisconsin, or North Dakota with suspected or confirmed Familial Hypercholesterolemia (FH) and high cholesterol levels despite taking medication. It's not for those who can't consent, pregnant women, prisoners, non-English speakers without research authorization, or if they have other conditions causing high cholesterol.

What is being tested?

The study tests whether motivational interviews can improve knowledge of FH and patient outcomes compared to usual care. Participants will be randomly assigned to either receive these interviews or continue with their regular treatment routine.

What are the potential side effects?

Since the intervention involves motivational interviewing—a psychological strategy to encourage positive behavior change—there are no direct medical side effects. However, participants may experience emotional discomfort discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on cholesterol medication but my LDL is over 124 or total cholesterol is over 195.

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I have or might have familial hypercholesterolemia (FH).

Select...

I am between 2 and 75 years old.

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I have a known FH mutation.

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I can understand and agree to the study's details.

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My cholesterol or LDL levels were high before treatment.

Exclusion Criteria

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

Select...

I have a condition like untreated thyroid issues or kidney problems that could be causing my high cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post enrollment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cascade screening of 1st degree family members

Knowledge of familial hypercholesterolemia

Secondary study objectives

Absolute change in LDL from baseline to follow up

Proportion of participants with LDL<100

Low-Density Lipoproteins

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Motivational InterviewExperimental Treatment1 Intervention

Motivational interview arm will receive a message to schedule a follow up motivational interview via telephone or video after the baseline survey as well as follow up surveys.

Group II: Usual CareActive Control1 Intervention

Usual care arm will receive baseline and follow up surveys only.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high cholesterol include statins, ezetimibe, and PCSK9 inhibitors. Statins work by inhibiting the enzyme HMG-CoA reductase, which reduces cholesterol production in the liver. Ezetimibe decreases cholesterol absorption in the intestines, while PCSK9 inhibitors increase the liver's ability to remove LDL cholesterol from the blood. These treatments are crucial for high cholesterol patients as they significantly lower the risk of cardiovascular events such as heart attacks and strokes. Motivational interviewing can enhance patient adherence to these treatments by increasing their motivation and commitment to lifestyle changes and medication regimens, ultimately improving health outcomes.