AdLip: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medication
AdLip
AdLip: Use of Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications: a Multi-centre Randomised Controlled Trial
1 other identifier
interventional
450
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedStudy Start
First participant enrolled
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
September 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2026
CompletedOctober 3, 2024
August 1, 2024
1.7 years
March 27, 2024
October 1, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluate effectiveness of adherence to lipid-lowering medication
Evaluate effectiveness of adherence to lipid-lowering medication through the use of pill counts
6 and 12 months
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.
6 and 12 months
Secondary Outcomes (10)
Blood LDL-cholesterol levels
6 and 12 months
Cardiovascular Risk score
6 and 12 months
Changes in health motivation and attitudes
6 and 12 months
Changes in self-care efficacy
6 and 12 months
Changes in self-care behaviours
6 and 12 months
- +5 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONReceive usual standard of care for lipid management
Standard care + Human Coach-supported Digital/AI Personal Health Assistant
EXPERIMENTALThe intervention group will receive personalised feedback through the digital mobile health app coupled with human coaching (i.e., support from a human coach-supported digital/AI personal health assistant) on top of usual clinical care for cholesterol management.
Interventions
Receive 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National University of Singaporelead
- National University Polyclinics, Singaporecollaborator
- Nanyang Technological Universitycollaborator
- National Healthcare Group Polyclinicscollaborator
- Consortium for Clinical Research and Innovation, Singapore (CRIS)collaborator
- National University Heart Centre, Singaporecollaborator
Study Sites (2)
National Healthcare Group Polyclinics
Singapore, 138543, Singapore
National University Polyclinics
Singapore, 609606, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Xian Chua
National University Polyclinics
- PRINCIPAL INVESTIGATOR
Ziliang Lim
National Healthcare Group Polyclinics
- PRINCIPAL INVESTIGATOR
Andy Khong
Nanyang Technological University
- PRINCIPAL INVESTIGATOR
Andy Hau Yan Ho
Nanyang Technological University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 27, 2024
First Posted
September 26, 2024
Study Start
June 10, 2024
Primary Completion
February 14, 2026
Study Completion
February 14, 2026
Last Updated
October 3, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share