DyslipidemiaNCT07094412
Patient-engaged Development and Testing of Educational Content on Side Effects of Statins
A study testing Educational content on statin side effects in people with Dyslipidemia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Educational content on statin side effects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2028to Sep 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-engaged Development and Pilot Testing of Educational Content to Improve Understanding of Pharmacological vs Nocebo Effects of Statins
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
- Being tested
- Educational content on statin side effects
- Keywords
- statin side effects, nocebo effect
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention arm | Experimental | Participants view educational content Receives: Other: Educational content on statin side effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of educational intervention
Number of enrolled participants who complete the educational intervention
Measured: 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.
Measured: 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."
Measured: Within 1 week of exposure to the educational content
Secondary outcomes (1)
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.
Measured: At baseline, within 1 week of exposure to the educational content and again 4-6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startSep 2028 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Why it stopped: Study has been put on hold due to change in investigator's other responsibilities and resulting insufficient time to carry out this study for the time being.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura F Gingras, MD, MSc, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094412
- Sponsor's protocol ID
- 25-05028924
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-engaged Development and Pilot Testing of Educational Content to Improve Understanding of Pharmacological vs Nocebo Effects of Statins
- ClinicalTrials.gov ID
- NCT07094412
- Acronym / sponsor ID
- 25-05028924
- Conditions
- Dyslipidemia
- Keywords
- statin side effects, nocebo effect
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study has been put on hold due to change in investigator's other responsibilities and resulting insufficient time to carry out this study for the time being.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2028 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational intervention arm | Experimental | Other: Educational content on statin side effectsParticipants view educational content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational content on statin side effectsParticipants 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. | Other | Educational intervention arm |
Primary outcome
Feasibility of educational intervention
Time frame: Within 1 week of enrollment
Number of enrolled participants who complete the educational intervention
Acceptability - satisfaction with educational intervention
Time frame: 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
Time frame: 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."
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura F Gingras, MD, MSc principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational content on statin side effects in people with Dyslipidemia, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of educational intervention (time frame: Within 1 week of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.