Patient-engaged Development and Testing of Educational Content on Side Effects of Statins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational content on statin side effects.
- Who it may be relevant to
- Registry conditions: Dyslipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-engaged Development and Pilot Testing of Educational Content to Improve Understanding of Pharmacological vs Nocebo Effects of Statins
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.
Interventions
- Other 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.
Primary outcome measures
- Feasibility of educational intervention [Time frame: Within 1 week of enrollment]
- Acceptability - satisfaction with educational intervention [Time frame: Within 1 week of exposure to educational content]
- Acceptability - likelihood to recommend educational content [Time frame: Within 1 week of exposure to the educational content]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT07094412 · 25-05028924