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

Completed · Not applicable

Conditions studied: Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Cardiovascular Diseases, Pharmacists, Placebo Effect

In brief

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.

Key facts

Study ID

NCT06423365

Run by

University of Utah

People needed

898

Starts

2024-10-24

Expected to finish

2026-05-01

Last updated by the study team

2026-05-29

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• KPCO member
• Sold a statin from KPCO pharmacy in the previous six months
• Have a gap of >1.0x the days' supply in refilling their statin
• Patient who stopped therapy (or delayed filling prescription) due to some perceived side effect
• Has email address available in kp.org (and therefore has access to a computer with internet)

You may not qualify if…

• Unable to verbalize comprehension of study or impaired decision-making
• Non-English speaking
• Limited life expectancy (e.g. hospice or palliative care)
• Pregnant or planning to become pregnant
• Patients on Kaiser Permanente's "do not call" list for research will also be excluded.

Where it is running

• Kaiser Permanente Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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