NCT06423365Completed
A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.
Development, Testing, and Implementation of Virtual Statin Associated Muscle Symptom Management
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 898 (actual)
- First submitted
- 20 Apr 2024
- Start date
- 24 Oct 2024
- Primary completion date
- 1 May 2026
- Lead sponsor
- University of Utah
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06423365
What you commit to
- Study type: Interventional
- Participants enrolled: 898
- From 24 Oct 2024 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 21 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiser Permanente Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.