Clinical trial NCT06423365: A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.
Official title: Development, Testing, and Implementation of Virtual Statin Associated Muscle Symptom Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypercholesterolemia
Cardiovascular Diseases
Pharmacists
Placebo Effect
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2024-05-21
Enrollment: 816
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who retry statin therapy
timeFrame: 30 days post-enrollment
measure: Number of participants who continue to take statin therapy
timeFrame: 6 months post-enrollment
Secondary outcomes:
measure: How adherent participants are to prescribed statin therapy
timeFrame: 6 months post-enrollment
Other outcomes:
measure: Proportion of participants satisfied with their treatment
timeFrame: 6 months post-enrollment
measure: Participant-reported decisional conflict
timeFrame: 1 month post-enrollment
measure: Participant-reported decision self-efficacy
timeFrame: 6 months post-enrollment
measure: Participant-reported perception of cardiovascular disease risk
timeFrame: 6 months post-enrollment
measure: Participant-reported degree of trust in healthcare
timeFrame: 6 months post-enrollment
measure: Participant-reported statin conspiracy beliefs
timeFrame: 6 months post-enrollment
measure: Participant-reported decision regret
timeFrame: 6 months post-enrollment
Locations:
Study officials:
affiliation: University of Utah
name: Jordan B King, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
References: