Investigation of a Patient Support Intervention for Statin Medication Adherence

NCT ID: NCT06972979

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-08-31

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.

Conditions

Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Text Message Group

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.

Group Type: EXPERIMENTAL

Text Message Gamification and Remote Support

Intervention Type: 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.

Interventions

Text 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Ascension Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Mitesh Patel

Chief Clinical Transformation Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ascension Health

St Louis, Missouri, United States

Countries

United States

Other Identifiers

RAS20250009

Identifier Type: -

Identifier Source: org_study_id