Hydroxymethylglutaryl-CoA Reductase Inhibitors1821534-10NCT06423365
A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.
A study testing Virtual Statin Management (VSM) in people with Hydroxymethylglutaryl-CoA Reductase Inhibitors and Hypercholesterolemia, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Cardiovascular Diseases
- What is being tested?
- Virtual Statin Management (VSM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 898 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy?
- Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy?
Read more
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.
- Conditions
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Cardiovascular Diseases, Pharmacists, Placebo Effect
- Being tested
- Virtual Statin Management (VSM)
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Statin Management (VSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who retry statin therapy
Measured using pharmacy dispensing records
Measured: 30 days post-enrollment
Number of participants who continue to take statin therapy
Measured using pharmacy dispensing records
Measured: 6 months post-enrollment
Secondary outcomes (1)
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)
Measured: 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start24 Oct 2024
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydroxymethylglutaryl-CoA Reductase InhibitorsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 898 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan King, University of Utah
- Investigators
- Jordan B King, PharmD, MS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423365
- Sponsor's protocol ID
- 1821534-10
- Other IDs
- R01HL157439
- Acronym
- 1821534-10
- Status last verified
- May 2026
- First submitted
- 20 Apr 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Testing, and Implementation of Virtual Statin Associated Muscle Symptom Management
- ClinicalTrials.gov ID
- NCT06423365
- Acronym / sponsor ID
- 1821534-10 / 1821534-10
- Conditions
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypercholesterolemia, Cardiovascular Diseases, Pharmacists, Placebo Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy?
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Usual Care + Virtual Statin Management (VSM) |
Primary outcome
Number of participants who retry statin therapy
Time frame: 30 days post-enrollment
Measured using pharmacy dispensing records
Number of participants who continue to take statin therapy
Time frame: 6 months post-enrollment
Measured using pharmacy dispensing records
1 secondary outcome
How adherent participants are to prescribed statin therapy
Time frame: 6 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan B King, PharmD, MS principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Statin Management (VSM) in people with Hydroxymethylglutaryl-CoA Reductase Inhibitors and Hypercholesterolemia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who retry statin therapy (time frame: 30 days post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.