AdLip: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-L… (NCT06614049) | Clinical Trial Compass
RecruitingNot Applicable
AdLip: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medication
Singapore450 participantsStarted 2024-06-10
Plain-language summary
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.
Who can participate
Age range
21 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
* In possession of a smartphone or tablet with Android or iOS operating systems.
* Have internet access on their mobile devices.
Exclusion Criteria:
* 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.
* Severe liver disease (Child-Pugh Class C)
* Existing muscular-related complaints or diagnoses which may confound adverse event reporting
* Uncorrected thyroid conditions, especially poorly-controlled hypothyroidism
* Documented psychiatric diagnosis or history of mental illness or deemed as unable to give informed consent.
* Currently pregnant, breastfeeding or expecting to get pregnant during the course of the study (1 year).
* Guarded prognosis with expectant mortality within 12 months or less.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate effectiveness of adherence to lipid-lowering medication
Timeframe: 6 and 12 months
2
Evaluate effectiveness of adherence to lipid-lowering medication