Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955625
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2023-07-13
Brief Title:
TIMELY a Patient-centred Lifestyle Program for Patients With Coronary Artery Disease
Sponsor:
Tilburg University
Organization:
Tilburg University
Study Overview
Official Title:
TIMELY A Patient-centred Lifestyle Program to Support the Continuum of Care in Patients With Coronary Artery Disease Using eHealth and Artificial Intelligence
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMELY
Brief Summary:
Study design A randomized controlled trial will be used where patients will be randomized 11 to either the control group receiving usual care or the intervention group in which patients will receive usual care in combination with the TIMELY intervention for a duration of 6 months
Study sample Female and male patients aged 18 years or over with documented stable CAD and referred for cardiac rehabilitation at 2 weeks but 10 weeks after PCI or 4 weeks but 12 weeks after CABG or MI STEM or non-STEMI andor having documented CAD by coronary angiography stenosis in a major coronary artery 50
Intervention Patients randomized to the intervention group will receive the TIMELY app on their phones or tablets for 6 months Patients will also receive a wearable activity tracker that collects activity levels heart rate and sleep characteristics Based on patients activity levels self-reported momentary mental states health-related behaviors and environmental and clinical background factors the app will enable patient-tailored recommendations relevant to improving lifestyle behaviors during daily life In addition patients will receive a blood pressure monitor that measures hemodynamic parameters through pulse wave analysis and an easy-to-use ECG device which will be used to assess changes in heart rate and other cardiovascular measures at rest and with exercise
Main study parametersendpoints The primary biomedical outcome is a change in the CoroPredict biomarker risk score from baseline pre-randomization to completion of the active intervention phase 6 months The CoroPredict score is an indicator of the 10-year risk of mortality The primary behavioral outcome is the change from baseline to 6 months in patients functional status of fitness level measured using the 6-minute walk test The study further aims to improve secondary outcome measures physical activity levels during daily life and cardiovascular responses to exercise dietary habits smoking behavior medication adherence and perceived levels of psychological stress
Study sample Female and male patients aged 18 years or over with documented stable CAD and referred for cardiac rehabilitation at 2 weeks but 10 weeks after PCI or 4 weeks but 12 weeks after CABG or MI STEM or non-STEMI andor having documented CAD by coronary angiography stenosis in a major coronary artery 50
Intervention Patients randomized to the intervention group will receive the TIMELY app on their phones or tablets for 6 months Patients will also receive a wearable activity tracker that collects activity levels heart rate and sleep characteristics Based on patients activity levels self-reported momentary mental states health-related behaviors and environmental and clinical background factors the app will enable patient-tailored recommendations relevant to improving lifestyle behaviors during daily life In addition patients will receive a blood pressure monitor that measures hemodynamic parameters through pulse wave analysis and an easy-to-use ECG device which will be used to assess changes in heart rate and other cardiovascular measures at rest and with exercise
Main study parametersendpoints The primary biomedical outcome is a change in the CoroPredict biomarker risk score from baseline pre-randomization to completion of the active intervention phase 6 months The CoroPredict score is an indicator of the 10-year risk of mortality The primary behavioral outcome is the change from baseline to 6 months in patients functional status of fitness level measured using the 6-minute walk test The study further aims to improve secondary outcome measures physical activity levels during daily life and cardiovascular responses to exercise dietary habits smoking behavior medication adherence and perceived levels of psychological stress
Detailed Description:
Background of the study
Cardiovascular diseases CVD are the leading cause of death globally according to the WHO The highest burden of disease among CVDs is caused by coronary artery disease CAD Ageing predisposes patients to a high incidence and prevalence of CAD in both men and women Older patients have the greatest mortality and morbidity risk attributable to Chronic Coronary Syndromes CCS partially due to the high prevalence of comorbidities Secondary prevention through comprehensive cardiac rehabilitation CR has been recognized as the most cost-effective intervention to limit the physiological and psychological effects of CVDs and reduce the risk of future cardiovascular events
Contrary to pharmacological or invasive interventions for CAD CR is far from being well implemented in all European countries and participation rates in available programs range between 30-50 of eligible patients The TIMELY platform has been developed to stimulate a healthy lifestyle after CR Patient-related barriers for digital health mainly involve the usability of the CR platform especially for older patients Thus TIMELY includes digital tools and interfaces that will not hinder senior citizens from using them as patient co-design has guided the development Since lifestyle changes are key in the prevention and self-management of CAD the main component of the TIMELY platform will be an app built on behavioral change techniques and models to empower and motivate patients to adopt a healthy lifestyle Artificial intelligence AI will be employed to adapt the platform to the most current needs of the patient In addition to prevention and self-management the TIMELY platform will constantly monitor and predict the individual risk for disease progression or serious events and complications using validated risk scores CoroPredict TIMELY will become the first AI-powered patient-centered eHealth platform that continuously adapts and customizes CR to meet the needs of patients
Objective of the study
1 To investigate whether the TIMELY intervention is superior to usual care in terms of A reducing the CoroPredict risk score indicating risk of 10-year mortality primary biomedical outcome from baseline to six months and B increasing functional fitness levels 6-minute walk test primary behavioral outcome from baseline to 6 months
Study design
A randomized controlled trial study design will be employed where patients will be randomized 11 to either the control group receiving usual care or the intervention group where patients will receive usual care in combination with the TIMELY intervention
Assessment will take place at 4 time points baseline 3 6 and 12 months post inclusion
Patients will be asked to fill out questionnaires at 4 timepoints baseline 3 months 6 months and 12 months Through the TIMELY-platform app patients in the intervention group will receive prompts to conduct and ECG and blood pressure measurement Patient in the intervention group will be wearing a Garmin which collects information about their physical activity patterns Lastly patients will receive physical assessments at three time points baseline 6 months and 12 months namely an exercise test and bloodwork will be done
Study population
Patients with documented CAD and who have been referred to cardiac rehabilitation at 2 weeks but 10 weeks after PCI or 4 weeks but 12 weeks after CABG or MI STEMI or non-STEMI andor have documented CAD by coronary angiography stenosis in a major coronary artery 50 will be included Recruitment will set special focus on women recruiting racialethnic minorities older adults rural residents and economically disadvantaged individuals
Intervention
1 Timely app
The TIMELY app will help patients adjust their lifestyle in order for them to become healthier The TIMELY app is supported by artificial intelligence and is based on behavioral change techniques Through the chatbots the messages aimed at changing the behavior of patients will be personalized Specific attention will be given to promoting physical activity Because the chatbots can take the physical context of the patient into account the odds of success are higher
2 Wrist-worn activity tracker
Patients will receive an activity tracker which will collect physical measures such as level of activity heart rate and sleep
3 Tel-O-Graph
Patients will receive a blood pressure monitor the Tel-O-Graph The device additionally measures other hemodynamic parameters through pulse wave analysis PWA
4 Net_ECG
Patients will receive an easy-to-use device capable of registering atrial fibrillation
5 eConnect HUB Patients will receive the eConnect HUB which will transfer all data from the Tel-O-Graph to the researchers
Patients will complete questionnaires at 4 timepoints baseline 3 months 6 months and 12 months In addition patients will have conversations with the chatbots in the app and based on this receive encouragement to perform certain behaviors eg exercise more or eat healthier Through the TIMELY platform app patients will receive messages to take their ECG and blood pressure readings Furthermore patients will wear a Garmin which will collect information about their exercise behavior Finally at the three measurement moments patients will receive an exercise test Blood will also be drawn at these times
Cardiovascular diseases CVD are the leading cause of death globally according to the WHO The highest burden of disease among CVDs is caused by coronary artery disease CAD Ageing predisposes patients to a high incidence and prevalence of CAD in both men and women Older patients have the greatest mortality and morbidity risk attributable to Chronic Coronary Syndromes CCS partially due to the high prevalence of comorbidities Secondary prevention through comprehensive cardiac rehabilitation CR has been recognized as the most cost-effective intervention to limit the physiological and psychological effects of CVDs and reduce the risk of future cardiovascular events
Contrary to pharmacological or invasive interventions for CAD CR is far from being well implemented in all European countries and participation rates in available programs range between 30-50 of eligible patients The TIMELY platform has been developed to stimulate a healthy lifestyle after CR Patient-related barriers for digital health mainly involve the usability of the CR platform especially for older patients Thus TIMELY includes digital tools and interfaces that will not hinder senior citizens from using them as patient co-design has guided the development Since lifestyle changes are key in the prevention and self-management of CAD the main component of the TIMELY platform will be an app built on behavioral change techniques and models to empower and motivate patients to adopt a healthy lifestyle Artificial intelligence AI will be employed to adapt the platform to the most current needs of the patient In addition to prevention and self-management the TIMELY platform will constantly monitor and predict the individual risk for disease progression or serious events and complications using validated risk scores CoroPredict TIMELY will become the first AI-powered patient-centered eHealth platform that continuously adapts and customizes CR to meet the needs of patients
Objective of the study
1 To investigate whether the TIMELY intervention is superior to usual care in terms of A reducing the CoroPredict risk score indicating risk of 10-year mortality primary biomedical outcome from baseline to six months and B increasing functional fitness levels 6-minute walk test primary behavioral outcome from baseline to 6 months
Study design
A randomized controlled trial study design will be employed where patients will be randomized 11 to either the control group receiving usual care or the intervention group where patients will receive usual care in combination with the TIMELY intervention
Assessment will take place at 4 time points baseline 3 6 and 12 months post inclusion
Patients will be asked to fill out questionnaires at 4 timepoints baseline 3 months 6 months and 12 months Through the TIMELY-platform app patients in the intervention group will receive prompts to conduct and ECG and blood pressure measurement Patient in the intervention group will be wearing a Garmin which collects information about their physical activity patterns Lastly patients will receive physical assessments at three time points baseline 6 months and 12 months namely an exercise test and bloodwork will be done
Study population
Patients with documented CAD and who have been referred to cardiac rehabilitation at 2 weeks but 10 weeks after PCI or 4 weeks but 12 weeks after CABG or MI STEMI or non-STEMI andor have documented CAD by coronary angiography stenosis in a major coronary artery 50 will be included Recruitment will set special focus on women recruiting racialethnic minorities older adults rural residents and economically disadvantaged individuals
Intervention
1 Timely app
The TIMELY app will help patients adjust their lifestyle in order for them to become healthier The TIMELY app is supported by artificial intelligence and is based on behavioral change techniques Through the chatbots the messages aimed at changing the behavior of patients will be personalized Specific attention will be given to promoting physical activity Because the chatbots can take the physical context of the patient into account the odds of success are higher
2 Wrist-worn activity tracker
Patients will receive an activity tracker which will collect physical measures such as level of activity heart rate and sleep
3 Tel-O-Graph
Patients will receive a blood pressure monitor the Tel-O-Graph The device additionally measures other hemodynamic parameters through pulse wave analysis PWA
4 Net_ECG
Patients will receive an easy-to-use device capable of registering atrial fibrillation
5 eConnect HUB Patients will receive the eConnect HUB which will transfer all data from the Tel-O-Graph to the researchers
Patients will complete questionnaires at 4 timepoints baseline 3 months 6 months and 12 months In addition patients will have conversations with the chatbots in the app and based on this receive encouragement to perform certain behaviors eg exercise more or eat healthier Through the TIMELY platform app patients will receive messages to take their ECG and blood pressure readings Furthermore patients will wear a Garmin which will collect information about their exercise behavior Finally at the three measurement moments patients will receive an exercise test Blood will also be drawn at these times
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None