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Enrolling by Invitation

NCT Number: NCT07094412

Patient-engaged Development and Testing of Educational Content on Side Effects of Statins

The purpose of this study is to learn about people's experiences and perspectives on side effects of statins and to use this information to develop and test educational content to help people understand statin side effects when they are newly prescribed a statin. Participants in the first phase of the study will fill out a survey and participate in a focus group or interview. Participants in the second phase of the study will view educational content, fill out a survey, and participate in two interviews.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has at least one cardiovascular risk factor, including diabetes (DM), hypertension (HTN), hyperlipidemia (HLD), or a 10-year risk of atherosclerotic cardiovascular disease (ASCVD) of equal to or greater than 7.5%
  • Able to speak and read English

Exclusion criteria

  • Established diagnosis of atherosclerotic cardiovascular disease (ASCVD), including coronary artery disease (CAD), peripheral arterial disease (PAD), or history of stroke
  • Unable to access and engage with web-based education content for any reason (either independently or with the help of a support person)
  • Is a healthcare professional at the college level or above, defined as a registered nurse, nurse practitioner, physician assistant, physician, dentist, or pharmacist
  • Has a graduate-level degree of any kind
  • Hospice or end-of-life

Treatment and study plan

Educational content on statin side effects

Other

Participants will view educational content that will include written material, graphics and video. The content will explain side effects and benefits of statin medications. The content will also explain placebo and nocebo effects and how they may impact people taking statins.

Primary outcomes

  1. Feasibility of educational intervention

    Time frame: Within 1 week of enrollment

    Number of enrolled participants who complete the educational intervention

  2. Acceptability - satisfaction with educational intervention

    Time frame: Within 1 week of exposure to educational content

    Participants are asked to rate their satisfaction with the educational content on a scale of 1-5, ranging from 1-very dissatisfied to 5-very satisfied.

  3. Acceptability - likelihood to recommend educational content

    Time frame: Within 1 week of exposure to the educational content

    Participants are asked how likely they are to recommend the educational content to friends or family, on a scale of 1 to 5, where 1 corresponds to "definitely will not recommend" and 5 corresponds to "definitely will recommend."

Secondary outcomes

  1. Change in knowledge of statin side effects and benefits

    Time frame: At baseline, within 1 week of exposure to the educational content and again 4-6 weeks later

    Participants will be asked a series of questions (some multiple choice and some open-ended) about statin side effects and benefits. This instrument will be developed by the investigators during the first phase of the study which will utilize focus groups to explore patients experiences and beliefs with regard to statin side effects.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Patient-engaged Development and Pilot Testing of Educational Content to Improve Understanding of Pharmacological vs Nocebo Effects of Statins

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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