Clinical trial NCT06972979: Investigation of a Patient Support Intervention for Statin Medication Adherence
Official title: A Randomized Trial of Gamification and Remote Support to Improve Statin Adherence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Medication Adherence
Keywords: Gamification
Remote Support
Statin
Adherence
Primary Care
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
Collaborators: name: Brigham and Women's Hospital
First posted: 2025-05-15
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Statin adherence, population average
timeFrame: 6-months after enrollment
Secondary outcomes:
measure: Statin adherence, proportion of population with PDC>=80%
timeFrame: 6-months after enrollment
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Ascension Health
state: Missouri
Study officials:
References: