Messaging Strategies for Cardiovascular Disease

(ADHERE-ASCVD Trial)

AS
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Overseen ByMirasol M Apostol-Largeteau, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
Must be taking: Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to encourage individuals with heart disease or diabetes to refill and adhere to their statin medications, which lower cholesterol. Researchers aim to determine if different communication methods, such as text messages, emails, or patient portal messages, can increase prescription refill rates compared to no additional messages. Participants may initially receive a text message reminder and, if they do not refill their prescription, a follow-up through another method like email. The trial is ideal for those with heart disease or diabetes who have not refilled their statin prescriptions in the past three months and have an active patient portal account. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance medication adherence strategies for many patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on improving statin refill and adherence, so it's likely you will continue your current medications unless advised otherwise by your doctor.

What prior data suggests that these messaging strategies are safe for improving statin adherence?

Past studies have shown that sending text messages (SMS) helps people remember to take medications for conditions like high cholesterol. For instance, reminder texts improved adherence to cholesterol-lowering drugs, resulting in better health outcomes. Only a few individuals reported issues with receiving these messages, while many found them useful.

Research suggests that secure portal messaging through online health portals aids in following medication schedules. This technology often reduces medication errors and enhances safety by facilitating clear communication between patients and healthcare providers.

The research on non-secure email is less definitive. Some studies have examined email reminders for medication adherence, but results are not consistently strong. The effectiveness of emails as reminders can depend on their content and delivery.

Overall, these messaging methods are safe and primarily serve to send reminders and information. Issues like missing a message or preferring a different communication method may arise, but these are usually minor concerns.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve adherence to dyslipidemia therapy, a crucial aspect of cardiovascular disease management. Unlike traditional methods that rely solely on patients remembering to refill their prescriptions, this trial tests the effectiveness of different messaging strategies, such as SMS, secure portal messages, and emails, to encourage timely statin refills. By examining which combination of reminders works best, the study aims to find out how to enhance patient compliance, potentially leading to better health outcomes. This approach could offer a simple yet impactful way to improve cardiovascular care by ensuring patients stick to their prescribed treatments.

What evidence suggests that this trial's messaging strategies could be effective for improving statin refill and adherence in patients with ASCVD or diabetes?

This trial will evaluate different messaging strategies to improve adherence to dyslipidemia therapy. Research has shown that text messages can help people remember to take their medication. In one study, text reminders increased the number of people taking their medication from 0% to 90%. Participants in this trial may receive SMS reminders as part of their treatment arm.

For secure online messages, studies have found that patients using online portals to refill prescriptions tend to take their medication more regularly. This method greatly improved prescription refill rates and effectively managed cholesterol levels. Some participants in this trial will receive secure portal messages as part of their treatment arm.

Regular email reminders also help, but the improvement is smaller. One study found a 4% increase in medication availability when patients received email reminders. Participants in this trial may receive non-secure email reminders as part of their treatment arm. Overall, different types of messaging can help people stick to their medication schedules, and this trial will explore these strategies.13678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with heart disease or diabetes who are Kaiser Permanente Northern California members, have not filled a statin prescription in the last 3 months, have less than 80% statin adherence over the past year, and have an active kp.org account plus valid email and text-capable phone.

Inclusion Criteria

6. Active kp.org account within the past 12 months
I have a valid email and a phone that can receive texts.
I am 18 years old or older.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Outreach

Participants receive an initial outreach message encouraging statin refill, with a 14-day window to refill

2 weeks
Remote monitoring

Follow-up Outreach

Non-responders receive a second outreach message using the same or different communication method

2 weeks
Remote monitoring

Follow-up

Participants are monitored for statin refill and adherence outcomes over a longer term

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Adherence to Dyslipidemia Therapy

Trial Overview

The study tests whether different ways of sending reminders—like text messages, secure portal messages, or emails—help people refill their statin prescriptions more than usual care. Some may get follow-up messages if they don't respond at first.

How Is the Trial Designed?

13

Treatment groups

Experimental Treatment

Active Control

Group I: Secure Portal Message/Usual CareExperimental Treatment1 Intervention
Group II: Secure Portal Message/Secure Portal MessageExperimental Treatment2 Interventions
Group III: Secure Portal Message/SMSExperimental Treatment2 Interventions
Group IV: Secure Portal Message/Non-secure EmailExperimental Treatment2 Interventions
Group V: SMS/Usual CareExperimental Treatment1 Intervention
Group VI: SMS/Secure Portal MessageExperimental Treatment2 Interventions
Group VII: SMS/SMSExperimental Treatment2 Interventions
Group VIII: SMS/Non-secure EmailExperimental Treatment2 Interventions
Group IX: Non-secure Email/Usual CareExperimental Treatment1 Intervention
Group X: Non-secure Email/Secure Portal MessageExperimental Treatment2 Interventions
Group XI: Non-secure Email/SMSExperimental Treatment2 Interventions
Group XII: Non-secure Email/Non-secure EmailExperimental Treatment2 Interventions
Group XIII: Usual Care/Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

Citations

Addressing adherence challenges in long-term statin ... - PMC

The study findings revealed a 4 % increase in medication possession ratios (MPRs) for dyslipidemia patients and a 5 % increase for diabetes ...

Adherence to Lipid‐Lowering Therapies and ...

To our knowledge, this is the first systematic review to evaluate the impact of adherence to statin or nonstatin LLTs on cardiovascular outcomes ...

Nonadherence to lipid‐lowering therapy and strategies ... - PMC

Adherence is critical for LLT effectiveness, with cumulative evidence linking poor LLT adherence and statin intolerance with worse outcomes and increased ...

Interventions to improve adherence to lipid-lowering drugs

Our findings show that while interventions were generally effective in improving medication adherence, both as continuous (SMD 0.17, 95% CI [ ...

Adherence to Statin Therapy and Attainment of LDL ...

Results: Overall, 80% of the patients had a statin prescription and of those, 89% were adherent. The proportion of patients who reached LDLc ...

Study Details | NCT07522645 | Adherence to Dyslipidemia ...

Participants will receive an initial non-secure email encouraging statin refill. Emails may include informational content and reminders but are delivered ...

Telehealth and challenges of statin adherence in patients with ...

The main hypothesis proposed that patients who consistently received SMS reminders would demonstrate higher medication adherence at follow-up ...

Improving Medication Adherence through Data-Centric Alerts

Harnessing data effectively allows clinicians to detect patterns, predict risks, and intervene proactively in cases of potential non-adherence.