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OpenTrials
Enrolling by Invitation

NCT Number: NCT06972979

Investigation of a Patient Support Intervention for Statin Medication Adherence

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ascension Health

St Louis, Missouri, 63134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, age 18 and older
  • Have a phone or email on file to receive 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.

Treatment and study plan

Text Message Gamification and Remote Support

Behavioral

Participants in the intervention arm consists of several 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.

Primary outcomes

  1. Statin adherence, population average

    Time frame: 6-months after enrollment

    Statin adherence, measured using the proportion of days covered (PDC), during the 6-month intervention period

Secondary outcomes

  1. Statin adherence, proportion of population with PDC>=80%

    Time frame: 6-months after enrollment

    Proportion of patients with statin PDC adherence greater than or equal to 80% during the 6-month intervention period

Sponsors and collaborators

Lead sponsor

Ascension Health

Industry

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

A Randomized Trial of Gamification and Remote Support to Improve Statin Adherence

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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