Dyslipidemia
Conditions
Keywords
statin side effects, nocebo effect
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.
Interventions
OTHEREducational 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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of educational intervention | Within 1 week of enrollment | Number of enrolled participants who complete the educational intervention |
| Acceptability - satisfaction with educational intervention | 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. |
| Acceptability - likelihood to recommend educational content | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed