Educational Content for Statin Side Effects and High Cholesterol

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: ASCVD, CAD, PAD, stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather insights from people who have experienced side effects from statins, drugs used to lower cholesterol. The goal is to create educational content that helps individuals understand these side effects when first prescribed statins. Participants will engage in surveys, focus groups, and interviews to share their experiences, then evaluate the educational materials. This trial suits individuals with risk factors like diabetes, high blood pressure, or high cholesterol, who can read and speak English. As an unphased trial, it offers participants a chance to contribute to valuable educational resources that can improve patient understanding and care.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational content about statin side effects, so you likely won't need to change your medication routine.

What prior data suggests that this educational content is safe?

Research has shown that statins are generally safe, with most people taking them without problems. Serious muscle injuries occur in less than 0.1% of users, and serious liver issues are even rarer, at about 0.001%. However, some individuals might experience muscle pain, digestive issues, or mental fog. While many tolerate statins well, about 5-30% of patients find them difficult to tolerate, which can lead to discontinuation. This study focuses on providing information about these side effects and poses no safety risks itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for high cholesterol involve medications like statins. But this study is unique because it focuses on educational content to help participants better understand the side effects of statins. Unlike traditional medications that directly lower cholesterol levels, this educational approach aims to empower patients by increasing their knowledge and potentially improving their adherence to statin therapy. Researchers are excited about this trial because better-informed patients might experience fewer side effects and stick with their prescribed treatments, leading to improved health outcomes.

What evidence suggests that this educational content is effective for understanding statin side effects?

Research shows that learning about statin side effects can help people understand what to expect when taking these medications. Studies have found that serious muscle problems from statins are very rare, yet many people stop taking them due to concerns about side effects. A review found the risk of serious liver problems to be extremely low, about 0.001%. However, those who stopped taking their statins reported feeling worse. In this trial, participants in the educational intervention arm will view content designed to provide clear information, addressing these concerns and helping people manage their cholesterol effectively. ^{3 5 6 7 8}

Who Is on the Research Team?

Laura F Gingras, MD, MSc

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic dyslipidemia or high cholesterol who are starting statin treatment. Participants will share their experiences and perspectives on statins' side effects through surveys, focus groups, or interviews.

Inclusion Criteria

Able to speak and read English

I have a heart risk factor like diabetes, high blood pressure, high cholesterol, or a high 10-year heart disease risk.

Exclusion Criteria

Unable to access and engage with web-based education content for any reason (either independently or with the help of a support person)

Has a graduate-level degree of any kind

Hospice or end-of-life

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1: Survey and Focus Group/Interview

Participants fill out a survey and participate in a focus group or interview to explore experiences and beliefs regarding statin side effects.

1 week

1 visit (in-person or virtual)

Phase 2: Educational Content and Interviews

Participants view educational content, fill out a survey, and participate in two interviews to assess the educational intervention.

1 week

2 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in knowledge of statin side effects and benefits.

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Educational content on statin side effects

Trial Overview The study aims to develop educational content based on patients' experiences with statins. It involves two phases: gathering insights via surveys and discussions, then testing the effectiveness of the created educational materials through participant feedback.

How Is the Trial Designed?

Group I: Educational intervention arm Experimental Treatment 1 Intervention

Participants view educational content

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602492/

Evidence review for statins: efficacy and adverse effects - NCBI The composite outcome of combined major adverse cardiovascular events was added. All previously included studies were reviewed and any data on this outcome was ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2090123224005988

Advances in statin adverse reactions and the potential ... This article provides a comprehensive review of the clinical manifestations of statin-related adverse reactions (associated myopathy, hepatotoxicity, ...

3. ahajournals.org ahajournals.org/doi/10.1161/atv.0000000000000073

Statin Safety and Associated Adverse Events: A Scientific ... The risk of statin-induced serious muscle injury, including rhabdomyolysis, is <0.1%, and the risk of serious hepatotoxicity is ≈0.001%.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6047411/

Adverse effects of statin therapy: perception vs. the evidence To objectively appraise evidence for possible adverse effects of long-term statin therapy on glucose homeostasis, cognitive, renal and hepatic function, and ...

5. lipid.org lipid.org/sites/default/files/files/statemanuscript.pdf

Experience of patients reporting side effects of statin therapy Respondents who discontinued statins reported significantly higher mean Symptom Severity (10.6 vs 8.7,. P , .001) and Impact Severity scores ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10892755/

Potential Benefits and Risks Associated with the Use of ... In general, statins are considered safe and well-tolerated medications, and they are the most commonly prescribed drugs worldwide. Clinical ...

7. mayoclinic.org mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/statin-side-effects/art-20046013

Statin side effects: Weigh the benefits and risks While statins are effective and safe for most people, they have been linked to muscle pain, digestive problems, and mental fuzziness in some people.

8. bmjgroup.com bmjgroup.com/new-study-sheds-light-on-long-term-effectiveness-and-safety-of-two-widely-used-statins/

New study sheds light on long term effectiveness and ... New study sheds light on long term effectiveness and safety of two widely used statins. Both drugs effective, but rosuvastatin carries higher risk of ...