About this trial
Investigators hypothesize that the use of a human coach-supported digital/AI personal health assistant (app) will improve adherence to cholesterol-lowering medications (statins with or without ezetimibe) among patients with hyperlipidaemia and suboptimal LDL-C control, when compared to standard care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between 21 to 84 years old
Prescribed statins with or without ezetimibe for hyperlipidaemia.
Medication non-adherence as defined by the "Extent to Non-adherence" sub-scale of the DOSE Non-Adherence Measure), with a score > 1 (range from 0-15)
Singapore residents (citizens, permanent residents, or long-term pass holders).
Disqualifiers
Does not read or understand English. Current use of smartphone medication adherence app(s) that include statins.
Concurrent use of PCSK9 Inhibitors in addition to statins and/or ezetimibe
Participation in another study that uses medications that could affect lipid levels
Severe renal impairment defined as chronic kidney disease stage 4 and above.
Trial design
Parallel
Treatments tested in this trial
Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications
BehavioralReceive personalised feedback and educational content curated by local clinicians and pharmacists through the CADENCE D-PHA app coupled with six sessions of human coaching on top of usual clinical care for lipid management over 6 months
Treatment groups
Trial outcomes
Primary outcomes
Evaluate effectiveness of adherence to lipid-lowering medication
Evaluate effectiveness of adherence to lipid-lowering medication through the use of pill counts
Evaluate effectiveness of adherence to lipid-lowering medication
Evaluate effectiveness of adherence to lipid-lowering medication through the use of Medication Adherence Report Scale-5 (MARS-5). The score ranges between 5 and 25, with higher scores indicating higher reported adherence.
Secondary outcomes
Blood LDL-cholesterol levels
Blood LDL-cholesterol levels compared with those receiving standard care.
Cardiovascular Risk score
Different in Singapore-modified Framingham Risk Scores between intervention and control groups. The risk scores range between -5 and 20 for men and between 0 and 27 for women. Higher scores indicate higher 10-year coronary artery disease risk.
Changes in health motivation and attitudes
Changes in health motivation and attitudes using Motivation and Attitude toward Changing Health (MATCH) Scale. It consists of 9 items rated on five-point Likert scale. Higher average scores indicate greater motivation and attitude.
Changes in self-care efficacy
Changes in self-care efficacy using Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. The scores range between 13 to 39, with higher scores indicating higher self-efficacy for medication adherence
Sponsors and contacts
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National University of Singapore
Lead sponsor
National University Polyclinics, Singapore
Collaborator
Nanyang Technological University
Collaborator
National Healthcare Group Polyclinics
Collaborator
Consortium for Clinical Research and Innovation, Singapore (CRIS)
Collaborator
National University Heart Centre, Singapore
Collaborator