AdLip Study of a Human Coach-supported DigitalAI Health Assistant to Help Adults with Hyperlipidemia Take Their Cholesterol Medicine

What this Trial Is About

This research aims to assess whether a human coach-supported digital and AI personal health assistant app can help improve how well patients with hyperlipidemia stick to their cholesterol-lowering medication plans compared to standard care. Hyperlipidemia is a major risk factor for heart attacks, and poor medication adherence leads to worse health outcomes and increased burden on individuals and health systems. The study is a multicenter, open-label, randomized controlled trial enrolling patients who are not fully following their statin medication regimens and have LDL cholesterol above recommended levels. Participants will be randomly assigned to one of two groups one receiving usual standard care for lipid management, and the other receiving the digitalAI health assistant app plus human coaching in addition to standard care. The intervention includes personalized feedback and educational content via the app along with six human coaching sessions over six months, designed to support medication adherence and general well-being. The coaching focuses strictly on adherence and does not involve medication changes, although concerns are escalated to pharmacists when needed. Participants will be followed for one year with visits at 3, 6, and 12 months to collect pill counts and clinical data. Clinical pharmacists will monitor and adjust medications as required as part of standard care. The study will evaluate adherence effectiveness at 6 and 12 months, along with secondary outcomes like LDL cholesterol levels, cardiovascular risk scores, health motivation, self-care behaviors, quality of life, and safety and acceptability of the new care model. A sub-study will collect patient insights on using the app and coaching to improve future interventions.

AdLip: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medication