ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-24
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06423365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * KPCO member
  2. * Sold a statin from KPCO pharmacy in the previous six months
  3. * Have a gap of \>1.0x the days' supply in refilling their statin
  4. * Patient who stopped therapy (or delayed filling prescription) due to some perceived side effect
  5. * Has email address available in kp.org (and therefore has access to a computer with internet)
  1. * Unable to verbalize comprehension of study or impaired decision-making
  2. * Non-English speaking
  3. * Limited life expectancy (e.g. hospice or palliative care)
  4. * Pregnant or planning to become pregnant
  5. * Patients on Kaiser Permanente's "do not call" list for research will also be excluded.

Contacts and Locations

Principal Investigator

Jordan B King, PharmD, MS
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Kaiser Permanente Colorado
Aurora, Colorado, 80011
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Jordan B King, PharmD, MS, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2024-10-24
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

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