Medication AdherenceNCT06972979
Investigation of a Patient Support Intervention for Statin Medication Adherence
A study testing Text Message Gamification and Remote Support in people with Medication Adherence, run by Ascension Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Text Message Gamification and Remote Support
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients will be excluded if they do not meet our inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial of Gamification and Remote Support to Improve Statin Adherence
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.
Read the 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
- Being tested
- Text Message Gamification and Remote Support
- Keywords
- Gamification, Remote Support, Statin, Adherence, Primary Care
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message Gamification and Remote SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Text Message Gamification and Remote Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin adherence, population average
Statin adherence, measured using the proportion of days covered (PDC), during the 6-month intervention period
Measured: 6-months after enrollment
Secondary outcomes (1)
Statin adherence, proportion of population with PDC>=80%
Proportion of patients with statin PDC adherence greater than or equal to 80% during the 6-month intervention period
Measured: 6-months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Krisda Chaiyachati, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972979
- Sponsor's protocol ID
- RAS20250009
- Status last verified
- Oct 2026
- First submitted
- 7 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study has patient information that the investigators are not approved to share.