Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423365
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-20
Brief Title:
A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Development Testing and Implementation of Virtual Statin Associated Muscle Symptom Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None