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HyperlipidemiaAdLipNCT06614049

AdLip: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medication

A study testing Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications in people with Hyperlipidemia and Medication Nonadherence, run by National University of Singapore at 2 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 84 yearsHealthy volunteers can take part
Conditions the study is for
Hyperlipidemia, Medication Nonadherence
What is being tested?
Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
2 sitesSingapore
Study dates
10 Jun 2024to 14 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Doreen Su-Yin Tan, Pharm.D. contact

66016471

doreen.tan.sy@nus.edu.sg

Singapore2 sites, 2 recruiting
  • National Healthcare Group Polyclinics

    Singapore, 138543

    TRO Admin, TRO@nhg.com.sg

    Recruiting
  • National University Polyclinics

    Singapore, 609606

    NUHS Research Office, partnership@nuhs.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: AdLip: Use of Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications: a Multi-centre Randomised Controlled 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.

Read the detailed description

Hyperlipidemia remains as one of the three leading metabolic risk factors underlying AMI onset by 2050. In recent study 3 Asian ethnicities with AMI, the incidence of hyperlipidemia is projected to increase by 205% (341 to 1041 per 100,000 population) from 2025 to 2050. A combination of lifestyle modifications and lipid-lowering therapy is typically recommended for individuals with high LDL-C levels to reduce the risk of CVD. The World Health Organization (WHO) defines adherence as "the extent to which the person's behaviour (including medication-taking) corresponds with agreed recommendations from a healthcare provider"

Poor medication adherence portends poorer health outcomes. In Singapore, around 60% of adults not taking their medications as prescribed (as above) and this creates a considerable economic and clinical burden to individuals and health systems.

The use of digital technology in medication adherence has continued to grow as more healthcare providers and patients recognise its benefits in improving adherence and overall health outcome. Digital interventions have effectively helped patients manage their medication by reminding patients to take their medications on time and providing them with more information about their medications and treatment plan. In the busy world today, the provision of appropriately timed and that perceived to be important would be key to effectively convince intentionally non-adherent patients to take their medicines as prescribed.

This study is a multicentre, open-label, two-arm parallel randomized controlled trial. We intent to randomly assign patients with hyperlipidaemia into one of the two groups: human coach-supported Digital/AI Personal Health Assistant app (intervention group) and standard care (control group) with a 1:1 allocation ratio. The intervention group will receive personalised feedback through the app coupled with human coaching on top of usual clinical care for cholesterol management. The control group will receive usual standard of care for lipid management but will not receive the personalised app nor have access to health coaching.

Participants with hyperlipidaemia (n=376) will be enrolled in polyclinics, and key inclusion criteria are participants who are non-adherent to statins "Extent to Non-adherence" sub-scale of the DOSE Non-Adherence Measure), with a score > 1 (range from 0-15) with or without on ezetimibe and have LDL-C level above the recommended target levels stratified by risk category. Participants will be followed up at Visit 2 @Month 3, Visit 3 @ Month 6 and Visit 4 @ Month 12 while pill counts will be collected @3m, 6m, and 12m visits. As part of Standard-of-Care, clinical pharmacist will follow-up with patients, titrating lipid-lowering medication (such as statin, ezetimibe etc) as required, and review and take action clinical blood test results.

Only those in intervention group, Human-AI-Health coach will use the information gathered by the AI chatbot to guide the targeted behavioural intervention during phone consultation. The scope of coaching will be strictly related to the medication adherence and general well-being. The coach will not start, stop, or titrate any medication. Coach will escalate concerns to clinical pharmacists when deemed fit. A sub-study of focus group discussion will be conducted with a nested sample of 30-50 intervention group patients. The aims are: (a) to collect insights from intervention patients on their experiences with the app and human health coaching, (b) insights into which intervention components work best for them and under what circumstances, (c) insights into concerns which might impact intervention effectiveness, (d) factors that draw their participation and sustained engagement, (e) factors that deter them from sustainable engagement, (f) factors that may lead other CVD patients to be more inclined to partake in such a intervention and (g) ideas and suggestions to make the intervention more appealing and effective.

Being tested
Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications
Medical subject headings
Hyperlipidemias, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering MedicationsBehavioural

    Also called Artificial Intelligence, Health Coaching, CADENCE D-PHA, Improve Adherence to Lipid-Lowering Medications

    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

Study groups in NCT06614049
Study groupRoleWhat they receive
Standard careNo interventionReceive usual standard of care for lipid management
Standard care + Human Coach-supported Digital/AI Personal Health AssistantExperimentalThe 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.
Receives: Behavioral: Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate effectiveness of adherence to lipid-lowering medication

    Evaluate effectiveness of adherence to lipid-lowering medication through the use of pill counts

    Measured: 6 and 12 months

  2. 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.

    Measured: 6 and 12 months

Secondary outcomes (10)
  1. Blood LDL-cholesterol levels

    Blood LDL-cholesterol levels compared with those receiving standard care.

    Measured: 6 and 12 months

  2. 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.

    Measured: 6 and 12 months

  3. 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.

    Measured: 6 and 12 months

  4. 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

    Measured: 6 and 12 months

  5. Changes in self-care behaviours

    Changes in self-care behaviours using EQ-5D-5L, where index scores range from -0.59 to 1, with 1 being the best possible health state. The accompanying EQ VAS scores range from 0 to 100, with 100 being the best possible health state.

    Measured: 6 and 12 months

  6. Changes in quality of life

    Change in quality of life using Single-Item Quality of Life Scale (SI-QOL). A seven-point scale is used, with higher score indicating better quality of life.

    Measured: 6 and 12 months

  7. Changes in quality of life

    Change in quality of life using Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale (FACIT-Sp). It consists of 12 items rated on a five-point Likert scale, with the total score ranging between 0 and 48. Higher total score indicates better spiritual wellbeing.

    Measured: 6 and 12 months

  8. Safety of a new model of care

    The health coaching integrated in the app is designed with a \"do no harm\" principle, ensuring that coaching interventions do not cause physical, psychological, or emotional harm to the participants. This principle is embedded both in the content delivered by the coaches and in the app.

    Adverse Event (AE) Monitoring:

    AE are uncommon for health coaching intervention. However, in the case that adverse psychological events do occur, (e.g., increased anxiety or nervousness), immediate emotional support will be provided. Health coaches will ensure that participants are in emotionally stable state through check-ins (built-in in the coaching checklist), and if necessary, refer them to the healthcare team. AE will be documented in the case notes. Participants will be encouraged to report any negative experiences /symptoms, related to the intervention by using the app or via direct communication with the coach. User feedback on the app-experiences will be collected.

    Measured: 6 and 12 months

  9. Acceptability of a new model of care

    Evaluate the acceptability of a new model of care with the use of Chatbot Usability Questionnaire. A higher score would imply better acceptability.

    Measured: 6 and 12 months

  10. Acceptability of a new model of care

    Evaluate the acceptability of a new model of care with the use of MHealth App Usability Questionnaire (MAUQ). A higher score would imply better acceptability.

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start10 Jun 2024
  3. Primary completion14 Feb 2026 (estimated)
  4. Study completion14 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group receives coaching from trained coaches and health-related information through an app, curated by coaches. Control group follows the standard of care of hyperlipidaemia patients.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06614049
Sponsor's protocol ID
2023/00438
Other IDs
2023
Acronym
AdLip
Status last verified
Aug 2024
First submitted
27 Mar 2024
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ong QC, Obarcanin E, Bojic I, Tan SH, Senanayake S, Kularatna S, Graves N, Chan SP, Sim JLM, Hausenloy D, Chan MYY, Khong AWH, Tan DS, Ho AHY. Health coach-supported mobile health intervention to improve adherence to lipid-lowering medications (AdLip): Design and rationale of a multicentre randomized controlled trial protocol. PLoS One. 2026 May 5;21(5):e0346509. doi: 10.1371/journal.pone.0346509. eCollection 2026.

    PubMed 42085423

Questions about this trial

What is this clinical trial studying?

A study testing Human Coach-supported Digital/AI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications in people with Hyperlipidemia and Medication Nonadherence, run by National University of Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Doreen Su-Yin Tan, Pharm.D. (66016471, doreen.tan.sy@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate effectiveness of adherence to lipid-lowering medication (time frame: 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06614049, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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