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

NCT ID: NCT07094412

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Educational intervention arm

Participants view educational content

Group Type EXPERIMENTAL

Educational content on statin side effects

Intervention Type 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.

Interventions

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Educational content on statin side effects

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura F Gingras, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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25-05028924

Identifier Type: -

Identifier Source: org_study_id

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