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

N/AEnrolling By InvitationNCT07094412

Weill Medical College of Cornell University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Dyslipidemia

Interventions

Educational content on statin side effectsOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Feasibility of educational intervention

Number of enrolled participants who complete the educational intervention

Time frame: 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.

Time frame: 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."

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

Secondary Outcomes

Change in knowledge of statin side effects and benefits

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.

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

Data from ClinicalTrials.gov

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