Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease
ADHERE-ASCVD
1 other identifier
interventional
22,000
1 country
1
Brief Summary
The goal of the ADHERE-ASCVD study is to evaluate and optimize patient-facing messaging strategies to improve statin refill and adherence among adults with atherosclerotic cardiovascular disease (ASCVD) or diabetes. The main questions it aims to answer are:
- Receive an initial outreach message encouraging statin refill (or usual care) Be monitored for statin refill within 14 days
- Potentially receive a second outreach message using the same or a different communication method if they do not initially refill their prescription
- Have their medication refill patterns tracked over time, including longer-term adherence outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedJuly 6, 2026
April 1, 2026
28 days
April 2, 2026
July 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Statin refill after message delivery
Proportion of participants who refill a statin prescription following message delivery (first-stage intervention) or, among non-responders, following second-stage messaging. Refill status will be determined using pharmacy dispensing records.
Within 14 days after each stage of message delivery
Secondary Outcomes (4)
Time to statin refill
Up to 30 days after each stage of message delivery
Statin refill
Within 30 days after message delivery
Statin persistence
At 6 months and 12 months post randomization.
Statin adherence (proportion of days covered)
At 6 months and 12 months post randomization.
Study Arms (13)
SMS/SMS
EXPERIMENTALParticipants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a second SMS.
SMS/Secure Portal Message
EXPERIMENTALParticipants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a secure portal message.
SMS/Non-secure Email
EXPERIMENTALParticipants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a non-secure email.
SMS/Usual Care
EXPERIMENTALParticipants in this arm will receive an initial SMS (text message) encouraging statin refill. Participants who do not refill their prescription within 14 days will receive no additional outreach (usual care).
Secure Portal Message/Secure Portal Message
EXPERIMENTALParticipants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a second secure portal message.
Secure Portal Message/SMS
EXPERIMENTALParticipants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive an SMS (text message).
Secure Portal Message/Non-secure Email
EXPERIMENTALParticipants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a non-secure email.
Secure Portal Message/Usual Care
EXPERIMENTALParticipants in this arm will receive an initial secure portal message encouraging statin refill. Participants who do not refill their prescription within 14 days will receive no additional outreach (usual care).
Non-secure Email/Non-secure Email
EXPERIMENTALParticipants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a second non-secure email.
Non-secure Email/SMS
EXPERIMENTALParticipants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive an SMS (text message).
Non-secure Email/Secure Portal Message
EXPERIMENTALParticipants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive a secure portal message.
Non-secure Email/Usual Care
EXPERIMENTALParticipants in this arm will receive an initial non-secure email encouraging statin refill. Participants who do not refill their prescription within 14 days will receive no additional outreach (usual care).
Usual Care/Usual Care
NO INTERVENTIONParticipants in this arm will receive usual care with no proactive outreach during the study period.
Interventions
Participants will receive an initial SMS (text message) encouraging statin refill. Messages may include reminder prompts and interactive features implemented through automated keyword-triggered responses that provide refill instructions or educational information.
Participants will receive an initial secure message through the kp.org patient portal encouraging statin refill. Messages are delivered within the secure portal environment and may include informational and reminder content.
Participants will receive an initial non-secure email encouraging statin refill. Emails may include informational content and reminders but are delivered outside of the secure patient portal.
Participants who do not refill their prescription within 14 days of the initial outreach will receive a follow-up SMS (text message) encouraging statin refill. Messages may include reminder prompts and interactive features implemented through automated keyword-triggered responses that provide refill instructions or educational information.
Participants who do not refill their prescription within 14 days of the initial outreach will receive a follow-up secure portal message through the kp.org patient portal encouraging statin refill. Messages are delivered within the secure portal environment and may include informational and reminder content.
Participants who do not refill their prescription within 14 days of the initial outreach will receive a follow-up non-secure email encouraging statin refill. Emails may include informational content and reminders but are delivered outside of the secure patient portal.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Active Kaiser Permanente Northern California (KPNC) membership
- No statin prescription fill within the prior 3 months
- Statin adherence \<80% in the prior 12 months
- Active kp.org account within the past 12 months
- Valid email address and text-capable phone number on file
You may not qualify if:
- Documented allergic reaction or contraindication to statin therapy
- Receiving hospice care
- Medicare beneficiaries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaiser Permenante Northern California
Pleasant Hill, California, 94588, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2026
First Posted
April 13, 2026
Study Start
April 14, 2026
Primary Completion
May 12, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
July 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share