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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423365
• Other study ID #: R01HL157439
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Jordan B King, PharmD, MS
• Phone: 801-213-8797
• Email: jordan.king[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 816
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Number of participants who retry statin therapy	Measured using pharmacy dispensing records	30 days post-enrollment
Primary	Number of participants who continue to take statin therapy	Measured using pharmacy dispensing records	6 months post-enrollment
Secondary	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