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 range21 Years – 84 Years
SexALL
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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.
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