Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease

NCT07522645 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22000

Last updated 2026-04-15

No results posted yet for this study

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:

1. Do different outreach methods (such as text messages, secure portal messages, or email) increase short-term statin refill compared to usual care?
2. Among patients who do not initially refill their prescription, does changing the outreach method improve refill rates?

The team with operational partners will evaluate the comparitive effectivessness of multiple messaging strategies delivered through existing health system communication channels, including SMS (text messaging), secure patient portal messages, non-secure email, and usual care (no additional outreach).

Participants

* 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

Conditions

Interventions

BEHAVIORAL

SMS (Initial Outreach)

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.

BEHAVIORAL

Secure Portal Message (Initial Outreach)

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.

BEHAVIORAL

Non-secure Email (Initial Outreach)

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.

BEHAVIORAL

SMS (Follow-up for Non-responders)

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.

BEHAVIORAL

Secure Portal Message (Follow-up for Non-responders)

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.

BEHAVIORAL

Non-secure Email (Follow-up for Non-responders)

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-14
Primary Completion
2026-05-30
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07522645 on ClinicalTrials.gov