Investigation of a Patient Support Intervention for Statin Medication Adherence

Ascension Health

Status: Not yet enrolling

Conditions: Medication Adherence

Treatments: Behavioral: Text Message Gamification and Remote Support

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06972979

RAS20250009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,200 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants in the usual care arm will have consented for participation and will be informed they are on a waiting list for approximately 6-12 months. During that time they will receive no additional interventions beyond usual care and not be be invited again to enroll in the MedTrack program.

Text Message Group

Experimental group

Description:

Participants in the intervention arm will have consented for participation in the MedTrack program and will receive the text message intervention and remote support within 1-2 weeks of enrolling.

Treatment:

Behavioral: Text Message Gamification and Remote Support