Actively Recruiting
Led by National University of Singapore · Updated on 2024-10-03
450
Participants Needed
2
Research Sites
N/A
Total Duration
N
National University of Singapore
Lead Sponsor
N
National University Polyclinics, Singapore
Collaborating Sponsor
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 digital/AI 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.
CONDITIONS
AdLip: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medication
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 6 months
Participants in the intervention group receive personalized feedback through a digital/AI personal health assistant app and six sessions of human coaching on top of usual clinical care for lipid management. Participants in the control group continue with usual standard of care for lipid management.
Visits at Month 3 and Month 6 (in-person) for follow-up and pill counts
Duration - 6 months
Participants continue with standard care and are monitored for medication adherence and health outcomes.
Visit at Month 12 (in-person) for follow-up and pill counts
Total: 2 locations
1
National Healthcare Group Polyclinics
Singapore, Singapore, 138543
Actively Recruiting
2
National University Polyclinics
Singapore, Singapore, 609606
Actively Recruiting
D
Doreen Su-Yin Tan, Pharm.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Qi Chwen Ong, Emina Obarcanin, Iva Bojic...
https://pubmed.ncbi.nlm.nih.gov/42085423