Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614049
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-27
Brief Title:
AdLip Human Coach-supported DigitalAI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medication
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AdLip Use of Human Coach-supported DigitalAI Personal Health Assistant to Improve Adherence to Lipid-Lowering Medications a Multi-centre Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AdLip
Brief Summary:
Investigators hypothesize that the use of a human coach-supported digitalAI 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
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 100000 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 persons 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 DigitalAI Personal Health Assistant app intervention group and standard care control group with a 11 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 n376 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
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 DigitalAI Personal Health Assistant app intervention group and standard care control group with a 11 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 n376 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None