Investigation of a Patient Support Intervention for Statin Medication Adherence

NCT06972979 | Not Yet Recruiting DMC

• 1 other identifier: RAS20250009
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Keywords

Gamification; Remote Support; Statin; Adherence; Primary Care

Outcome Measures

Primary Outcomes (1)

• Statin adherence, population average

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

  6-months after enrollment

Secondary Outcomes (1)

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

  6-months after enrollment

Study Arms (2)

Usual Care

NO INTERVENTION

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

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.

Behavioral: Text Message Gamification and Remote Support

Interventions

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.

Text Message Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ascension Health: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Ascension Health

St Louis, Missouri, 63134, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical Transformation Officer

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)