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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

816 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia Cardiovascular Diseases Pharmacists Placebo Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Virtual Statin Management (VSM)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes