Skip to content

Investigation of a Patient Support Intervention for Statin Medication Adherence

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06972979
Enrollment
2200
Registered
2025-05-15
Start date
2026-04-20
Completion date
2027-05-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence

Keywords

Gamification, Remote Support, Statin, Adherence, Primary Care

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.

Interventions

BEHAVIORALText Message Gamification and Remote Support

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.

Sponsors

Ascension Health
Lead SponsorINDUSTRY
Brigham and Women's Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

This is a two-arm, randomized, controlled trial to test the effectiveness of a behaviorally-designed gamification intervention with remote nursing support to increase statin adherence after 6-months. Patients will be randomized after they opt-in and consent for the program within the following Ascension states: FL, IN, TN, TX.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Statin adherence, population average6-months after enrollmentStatin adherence, measured using the proportion of days covered (PDC), during the 6-month intervention period

Secondary

MeasureTime frameDescription
Statin adherence, proportion of population with PDC>=80%6-months after enrollmentProportion of patients with statin PDC adherence greater than or equal to 80% during the 6-month intervention period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026