NCT06423365

A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.

Development, Testing, and Implementation of Virtual Statin Associated Muscle Symptom Management

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 816 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are: 1. Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy? 2. Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy? Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change. All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed.

Conditions

• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Hypercholesterolemia
• Cardiovascular Diseases
• Pharmacists
• Placebo Effect

Interventions

Type	Name	Description
OTHER	Virtual Statin Management (VSM)	VSM is a web-based decision aid to help manage statin therapy after experiencing muscle pain perceived to be caused or worsened by their statin therapy. The introduction will feature a brief explanation of the tool and what they can expect. The modules are: 1. General education (lipids, heart disease, medications) 2. Side effects (causes, diagnosis). 3. Statin modifications. VSM will guide patients to understand their lipid-lowering options, particularly their statin options that may best match patients' stated preferences. 4. ASCVD risk \& statin benefit. Finally, the VSM experience will end by providing the patient with a summary of the results of their use of the tool, which can be used during discussions with their healthcare provider. The information gathered from the VSM will remain confidential and will not be disclosed to anyone other than the patient.

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-05-21
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States