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

NCT06423365 | Active Not Recruiting

• 2 other identifiers: 1821534-10R01HL157439
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy?

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of participants who retry statin therapy

  Measured using pharmacy dispensing records

  30 days post-enrollment

• Number of participants who continue to take statin therapy

  Measured using pharmacy dispensing records

  6 months post-enrollment

Secondary Outcomes (1)

• How adherent participants are to prescribed statin therapy

  6 months post-enrollment

Other Outcomes (7)

• Proportion of participants satisfied with their treatment

  6 months post-enrollment

• Participant-reported decisional conflict

  1 month post-enrollment

• Participant-reported decision self-efficacy

  6 months post-enrollment

Study Arms (2)

Usual care

NO INTERVENTION

Participants randomized to usual care will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions.

Usual Care + Virtual Statin Management (VSM)

EXPERIMENTAL

Participants randomized to usual care + virtual statin management (VSM) will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions, and they will also be given a link to engage with the VSM website. The VSM website is an educational tool which has four principal components: 1) learning how to distinguish if and when muscle symptoms are caused by the statin; 2) learning the essentials about heart disease, focusing on causes, risk factors, and the crucial role of cholesterol management in prevention; exploring various cholesterol lowering options, including when it makes sense to retry a statin and what options exist beyond statins; and 4) learning to engage in productive discussions with healthcare providers and set effective treatment goals together.

Other: Virtual Statin Management (VSM)

Interventions

Virtual Statin Management (VSM) OTHER

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.

Usual Care + Virtual Statin Management (VSM)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Utah: lead
• Kaiser Permanente: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Kaiser Permanente Colorado

Aurora, Colorado, 80011, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jordan B King, PharmD, MS

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 21, 2024
• Study Start: October 24, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-07

Locations

US (1)