Skip to main content
OpenTrials
Completed

NCT Number: NCT06423365

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hydroxymethylglutaryl-CoA Reductase Inhibitors Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pharmacists Placebo Effect

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Colorado

Aurora, Colorado, 80011, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. Number of participants who retry statin therapy

    Time frame: 30 days post-enrollment

    Measured using pharmacy dispensing records

  2. Number of participants who continue to take statin therapy

    Time frame: 6 months post-enrollment

    Measured using pharmacy dispensing records

Secondary outcomes

  1. How adherent participants are to prescribed statin therapy

    Time frame: 6 months post-enrollment

    Measured using pharmacy dispensing records, using the proportion of days' covered calculation metric (range: 0-100%, where 100% means perfectly adherent)

Other outcomes

  1. Proportion of participants satisfied with their treatment

    Time frame: 6 months post-enrollment

    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.

  2. Participant-reported decisional conflict

    Time frame: 1 month post-enrollment

    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.

  3. Participant-reported decision self-efficacy

    Time frame: 6 months post-enrollment

    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.

  4. Participant-reported perception of cardiovascular disease risk

    Time frame: 6 months post-enrollment

    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.

  5. Participant-reported degree of trust in healthcare

    Time frame: 6 months post-enrollment

    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. Participant-reported statin conspiracy beliefs

    Time frame: 6 months post-enrollment

    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.

  7. Participant-reported decision regret

    Time frame: 6 months post-enrollment

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Kaiser Permanente
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: 1821534-10

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 21, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.