The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change technique (BCT) intervention required to increase statin medication adherence among Black and African American individuals on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The long-term goal is to prevent CVD among Black and African American individuals. The current project will utilize a modified version of the time-to-event continual reassessment method (TiTE-CRM), a state of the art dose finding methodology, to determine the MED of a multi-component BCT intervention required to increase the proportion of days adherent to statin medications by 20%. The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues.
The study sample will include individuals who identify as Black or African American and are currently prescribed primary prevention statin therapy. For this research, the investigators will enroll participants with low levels of self-reported adherence to statin medications, with the goal of randomizing 42 persons to the intervention. Enrolled participants will complete a 2-week run-in period where levels of adherence to statin medications will be assessed using a smart pill bottle and physical activity levels will be measured using a Fitbit wearable device. During the run-in period, data from the smart pill bottle will be used to verify objective non-adherence to statin medications (defined as taking statin medications as prescribed for less than 80% of days). Individuals who do not meet objective levels of nonadherence to statin medications and/or are non-adherent to the protocol will be excluded and will not be randomized to the intervention. Following the run-in, the investigators will randomize 42 participants into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose of a multi-BCT intervention. Assignment to doses will utilize modified TiTE-CRM methodology to adjust the dose for each cohort based on the results from the previous cohort. Following the intervention, all participants will be assessed over a 2-week follow-up period which includes passive data collection from the activity monitor, answering surveys and use of the electronic pill bottle to track medication adherence. The MED will be defined as the smallest BCT dose duration associated with a 20% increase in the proportion of days using statin medication as prescribed between the run-in and the follow-up periods in 80% of the sample receiving that dose. Adherence to statins will be defined using changes in weight of medication in the smart pill bottle. The investigators will also assess Mechanisms of Action (MoAs) to determine potential mediators of the BCT intervention on physical activity (PA). As some evidence suggests there are correlations between adherence and PA and that interventions targeting medication adherence also influence PA, the investigators will utilize Fitbit devices to determine whether the BCT intervention increase participant’s levels of activity.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
