Investigation of a Patient Support Intervention for Statin Medication Adherence

Not Applicable

Not yet recruiting

• Conditions: Medication Adherence

• Registration Number: NCT06972979
• Lead Sponsor: Ascension Health

Brief Summary

Statins have been demonstrated to significantly reduce the risk of cardiovascular disease, but adherence to these medications is suboptimal. Improving adherence can be challenging because it is multifactorial and behaviors often occur within the everyday lives of patients and are less addressable during a visit with a clinician. In this study, the investigators will conduct a randomized trial to evaluate a behaviorally-designed gamification intervention with remote nursing support to improve statin adherence.

Detailed Description

Improving medication adherence can be challenging because behaviors occur within the everyday lives of patients. Therefore, intermittent visit-based adherence interventions or refill reminders have had limited impact. Remote Patient Monitoring (RPM) has been demonstrated in other settings to improve daily health behaviors when combined with automated outreach and a behavioral change strategy, such as gamification. These approaches have been demonstrated to be effective for other daily behaviors such as increasing physical activity levels among a wide range of patient populations including those at elevated risk for major cardiovascular events. MedTrack is a text message-based remote patient monitoring program with several key components: (I) medication check-ins with the ability to set the time(s) for daily medication reminders, (II) a gamification experience to drive behavior change, (III) ability to identify a support partner who receives weekly updates on the patient's game status; (IV) access to an RN team for clinical questions and care coordination, and (V) patients' providers can see real-time progress within an electronic health record (EHR) integrated application.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Study Start: 2025-08
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Adults, age 18 and older
• Have a mobile phone number or email on file to receive a digital outreach to participate in the study
• Have a primary care provider (PCP) employed by Ascension.
• Prescribed a statin medication and had filled two statin prescriptions in the previous 12 months (one in the prior 6 months and another in the previous 6 to 12 months)
• PDC <80% in the prior 12 months
• Have consented for electronic communications with Ascension

Exclusion Criteria

• Patients will be excluded if they do not meet our inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Statin adherence, population average	6-months after enrollment	Statin adherence, measured using the proportion of days covered (PDC), during the 6-month intervention period

Secondary Outcome Measures

Name	Time	Method
Statin adherence, proportion of population with PDC>=80%	6-months after enrollment	Proportion of patients with statin PDC adherence greater than or equal to 80% during the 6-month intervention period

Trial Locations

Locations (1)

Ascension Health; 🇺🇸 St. Louis, Missouri, United States