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

NCT07094412 | Suspended

• 1 other identifier: 25-05028924
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslipidemia

Keywords

statin side effects; nocebo effect

Outcome Measures

Primary Outcomes (3)

• Feasibility of educational intervention

  Number of enrolled participants who complete the educational intervention

  Within 1 week of enrollment

• Acceptability - satisfaction with educational intervention

  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.

  Within 1 week of exposure to educational content

• Acceptability - likelihood to recommend 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."

  Within 1 week of exposure to the educational content

Secondary Outcomes (1)

• Change in knowledge of statin side effects and benefits

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

Study Arms (1)

Educational intervention arm

EXPERIMENTAL

Participants view educational content

Other: Educational content on statin side effects

Interventions

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.

Educational intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Laura F Gingras, MD, MSc

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start (Estimated): September 1, 2028
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)