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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06423365
Other study ID # R01HL157439
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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