A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. (1821534-10)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypercholesterolemia; Placebo Effect; Pharmacists; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Intervention / Treatment: Other: Virtual Statin Management (VSM)

• Study Type: Interventional
• Enrollment (Actual): 898
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Kaiser Permanente Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Participants randomized to usual care will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions.
Experimental: Usual Care + Virtual Statin Management (VSM); 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); 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: General education (lipids, heart disease, medications); Side effects (causes, diagnosis).; Statin modifications. VSM will guide patients to understand their lipid-lowering options, particularly their statin options that may best match patients' stated preferences.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
How adherent participants are to prescribed statin therapy	Measured using pharmacy dispensing records, using the proportion of days' covered calculation metric (range: 0-100%, where 100% means perfectly adherent)	6 months post-enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-reported decisional conflict	Assessed using the Decisional Conflict Scale, 10-item, 3-response (https://decisionaid.ohri.ca/docs/develop/Tools/DCS_LowLiteracy_English.pdf). Participants indicate "yes", "unsure", or "no" to 10 questions assessing their decisional conflict regarding their decision to use cholesterol-lowering medication.	1 month post-enrollment
Proportion of participants satisfied with their treatment	Assessed using two questions inspired by the Treatment Satisfaction with Medication Questionnaire. Participants the degree to which they agree or disagree (5-point Likert) regarding their satisfaction with cholesterol-lowering medication.	6 months post-enrollment
Participant-reported decision self-efficacy	Measured using the Decision Self-Efficacy Scale, 11-item, 3-response (https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf). Participants indicate their level of confidence from 0 (not at all confident) to 4 (very confident) regarding their decision to use cholesterol-lowering medication.	6 months post-enrollment
Participant-reported perception of cardiovascular disease risk	Adapted from 3 questions used in the Prospective Assessment of Lipid Management (PALM) registry (https://classic.clinicaltrials.gov/ct2/show/NCT02341664). Participants indicate their perceived risk for having a heart disease event.	6 months post-enrollment
Participant-reported degree of trust in healthcare	Measured using the Trust in Physician Scale, 11-item (https://pubmed.ncbi.nlm.nih.gov/2084735/). Participants indicate the degree to which they agree or disagree (5-point Likert scale) with statements regarding their trust in healthcare personnel.	6 months post-enrollment
Participant-reported statin conspiracy beliefs	Participants indicate the degree to which they agree or disagree with 18 statements regarding potential statin-related harms or conspiracies. Answer options of strongly disagree, disagree, neither agree nor disagree, agree, strongly agree, or Not sure. Agreement with the statement indicates a negative belief about statins.	6 months post-enrollment
Participant-reported decision regret	Measured using the Decision Regret Scale, 5-item, 5-response (https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf). Participant indicate the degree to which they agree or disagree (5-point Likert Scale) with 5 statements regarding their choice to use cholesterol-lowering medication.	6 months post-enrollment

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Kaiser Permanente
• Investigators: Principal Investigator: Jordan B King, PharmD, MS, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Hypercholesterolemia
• Other Study ID Numbers: 1821534-10; R01HL157439 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No