Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03415841
Status:
UNKNOWN
Last Update Posted:
2019-05-07
First Post:
2017-10-24
Brief Title:
Kardia - A Smartphone-based Care Model for Outpatient Cardiac Rehabilitation
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
Kardia - A Smartphone-based Care Model for Outpatient Cardiac Rehabilitation
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
This study hopes to target the remaining 80 of low risk post-myocardial infarction patients who have refused uptake the traditional cardiac rehabilitation program In Changi General Hospital This is a 6-week home-based Cardiac rehabilitation program enabling patients to track their blood pressure physical activity and medicine compliance through a mobile application Each patient in the intervention arm is provided with a blood pressure monitor activity tracker and a single lead ECG monitor The data from these devices would be automatically synced by a mobile application and uploaded to a confidential web portal which is only accessible by physician care-givers The application also provides educational contenttasks appropriate reminders for taking medications and daily goals on activity targets set by the care provider This would help to engage the patients to enable behavioural change and improve compliance to mediation and activity recommendations
In general 50 patients who are randomized to the intervention group mHealth will be enabled with remote monitoring devices ECG Blood Pressure Activity tracker and Kardia mobile application for home-based rehabilitation program followed by review in the outpatient Cardiology clinics The control group 50 subjects will just be monitored at fixed intervals in the outpatient Cardiology clinics Fu AT 3-4 months 9-12 months Subjects will be advised to commence the exercise program 2 weeks after the myocardial infarction Block randomization using sequentially numbered sealed envelopes would be used to assign subjects to the intervention or control arms The primary outcome measure is compliance and adherence to the Kardia program Other endpoints include 6MWT patient wellbeing and behaviour eg dietary habits stress levels physical activity assessed using questionnaires major adverse cardiovascular events MACE modification of cardiovascular risk profiles ie LDL BP BMI HbA1c etc and medicine compliance
In general 50 patients who are randomized to the intervention group mHealth will be enabled with remote monitoring devices ECG Blood Pressure Activity tracker and Kardia mobile application for home-based rehabilitation program followed by review in the outpatient Cardiology clinics The control group 50 subjects will just be monitored at fixed intervals in the outpatient Cardiology clinics Fu AT 3-4 months 9-12 months Subjects will be advised to commence the exercise program 2 weeks after the myocardial infarction Block randomization using sequentially numbered sealed envelopes would be used to assign subjects to the intervention or control arms The primary outcome measure is compliance and adherence to the Kardia program Other endpoints include 6MWT patient wellbeing and behaviour eg dietary habits stress levels physical activity assessed using questionnaires major adverse cardiovascular events MACE modification of cardiovascular risk profiles ie LDL BP BMI HbA1c etc and medicine compliance
Detailed Description:
Cardiovascular disease CVD is the most common cause of death in Singapore accounting for 34 of deaths This means 1 in every 3 deaths in Singapore is due to heart disease or stroke Ischemic heart disease is the leading cause of mortality and accounts for 17 of all deaths attributable to life-style related risk-factors The total burden of this disease is likely to increase given the aging population and the increase in prevalence of obesity and predisposing conditions such as diabetes mellitus hypertension and hyperlipidaemia
A number of modifiable environmental and patient specific factors increase the chance of developing coronary artery disease These include smoking high blood cholesterol physical inactivity diabetes high blood pressure and obesity Following myocardial infarction acute coronary syndromes surgical and percutaneous interventions cardiac rehabilitation has provided an avenue for reducing future cardiovascular risks in patients by positively influencing these factors The eventual goal of the program is to engage patients with permanent behavioural and life-style changes There is strong evidence for the effectiveness of cardiac rehabilitation which is given a Class 1 recommendation from the AmericanEuropean Cardiology guidelines particularly for post-myocardial infarction patients Several studies and meta-analyses have demonstrated a significant reduction in mortality and morbidity
Despite the clear benefits of cardiac rehabilitation programs the uptake of these programs has been poor due to various patient and system factors Cardiac rehabilitation programs are traditionally carried out in hospitals and health centres under the direct personal supervision of mentoring clinicians Patient barriers such as time constraints and distance from treatment centres lead to poor uptake of programs among eligible patients To overcome these barriers home-based care models have been proposed as a viable alternative to hospital-based cardiac rehabilitation programs even in the 1980s The current state of mobile phone communication and technology provides not only the capacity but an especially attractive media option to support home-based cardiac rehabilitation programs
This study aims to investigate a smartphone-based cardiac rehabilitation program for patients recovering from myocardial infarction The program focuses on providing patient centric self-monitoring platform enabling patients to take control and be actively involved in their medical care The program Kardia is a 6-week rehabilitation program enabling patients to track their blood pressure physical activity and medicine compliance through a mobile application Each patient in the intervention arm is provided with a blood pressure monitor and activity tracker The data from these devices would be automatically synced by a mobile application and uploaded to a confidential web portal which is only accessible by physician care-givers The application also provides educational contenttasks appropriate reminders for taking medications and daily goals on activity targets set by the care provider This would help to engage the patients to enable behavioural change and improve compliance to mediation and activity recommendations
In Changi General Hospital the uptake of cardiac rehabilitation among eligible patients is less than 20 This study hopes to target the remaining 80 of patients who have refused the traditional cardiac rehabilitation program It will be the first time that a smartphone based home cardiac rehabilitation program would be offered in Singapore If shown to be safe and feasible Kardia will help to improve patient outcomes in short to medium term In addition it may empower the patients to take a more active role in their medical care and promote long lasting behavioural changes in the long term There will also be a significant operation impact if Kardia can be rolled out as an alternative care model to the traditional centre-based cardiac rehabilitation program enabling greater patient access to cardiac rehabilitation This is also in line with national initiatives to promote an active and healthy lifestyle ie National Steps Challenge by the Health Promotion Board
The project is a randomized controlled study of smartphone based cardiac rehabilitation program compared to routine care in patients who did not sign up for traditional hospital-based cardiac rehabilitation 50 patients who are randomized to the intervention group mHealth will be enabled with remote monitoring devices Blood Pressure and wearable vital signs monitor Biovotion and Kardia mobile application for home-based rehabilitation program followed by review in the outpatient Cardiology clinics The control group 50 patients will just be monitored at fixed intervals in the outpatient Cardiology clinics
Patients will be advised to commence the exercise program 2 weeks after the myocardial infarction
Time Exercise Intensity Exercise FrequencyDuration Patient actions Week 1 light 3xweek 10 minutes Exercise diary Week 2 light 3xweek 20 minutes Week 3 light 3xweek 30 minutes Week 4 moderate 3xweek 15 minutes Week 5 moderate 3xweek 30 minutes Week 6 moderate 4xweek 30 minutes Week 7 moderate 5xweek 30 minutes Week 8 moderate 5xweek 30 minutes
A number of modifiable environmental and patient specific factors increase the chance of developing coronary artery disease These include smoking high blood cholesterol physical inactivity diabetes high blood pressure and obesity Following myocardial infarction acute coronary syndromes surgical and percutaneous interventions cardiac rehabilitation has provided an avenue for reducing future cardiovascular risks in patients by positively influencing these factors The eventual goal of the program is to engage patients with permanent behavioural and life-style changes There is strong evidence for the effectiveness of cardiac rehabilitation which is given a Class 1 recommendation from the AmericanEuropean Cardiology guidelines particularly for post-myocardial infarction patients Several studies and meta-analyses have demonstrated a significant reduction in mortality and morbidity
Despite the clear benefits of cardiac rehabilitation programs the uptake of these programs has been poor due to various patient and system factors Cardiac rehabilitation programs are traditionally carried out in hospitals and health centres under the direct personal supervision of mentoring clinicians Patient barriers such as time constraints and distance from treatment centres lead to poor uptake of programs among eligible patients To overcome these barriers home-based care models have been proposed as a viable alternative to hospital-based cardiac rehabilitation programs even in the 1980s The current state of mobile phone communication and technology provides not only the capacity but an especially attractive media option to support home-based cardiac rehabilitation programs
This study aims to investigate a smartphone-based cardiac rehabilitation program for patients recovering from myocardial infarction The program focuses on providing patient centric self-monitoring platform enabling patients to take control and be actively involved in their medical care The program Kardia is a 6-week rehabilitation program enabling patients to track their blood pressure physical activity and medicine compliance through a mobile application Each patient in the intervention arm is provided with a blood pressure monitor and activity tracker The data from these devices would be automatically synced by a mobile application and uploaded to a confidential web portal which is only accessible by physician care-givers The application also provides educational contenttasks appropriate reminders for taking medications and daily goals on activity targets set by the care provider This would help to engage the patients to enable behavioural change and improve compliance to mediation and activity recommendations
In Changi General Hospital the uptake of cardiac rehabilitation among eligible patients is less than 20 This study hopes to target the remaining 80 of patients who have refused the traditional cardiac rehabilitation program It will be the first time that a smartphone based home cardiac rehabilitation program would be offered in Singapore If shown to be safe and feasible Kardia will help to improve patient outcomes in short to medium term In addition it may empower the patients to take a more active role in their medical care and promote long lasting behavioural changes in the long term There will also be a significant operation impact if Kardia can be rolled out as an alternative care model to the traditional centre-based cardiac rehabilitation program enabling greater patient access to cardiac rehabilitation This is also in line with national initiatives to promote an active and healthy lifestyle ie National Steps Challenge by the Health Promotion Board
The project is a randomized controlled study of smartphone based cardiac rehabilitation program compared to routine care in patients who did not sign up for traditional hospital-based cardiac rehabilitation 50 patients who are randomized to the intervention group mHealth will be enabled with remote monitoring devices Blood Pressure and wearable vital signs monitor Biovotion and Kardia mobile application for home-based rehabilitation program followed by review in the outpatient Cardiology clinics The control group 50 patients will just be monitored at fixed intervals in the outpatient Cardiology clinics
Patients will be advised to commence the exercise program 2 weeks after the myocardial infarction
Time Exercise Intensity Exercise FrequencyDuration Patient actions Week 1 light 3xweek 10 minutes Exercise diary Week 2 light 3xweek 20 minutes Week 3 light 3xweek 30 minutes Week 4 moderate 3xweek 15 minutes Week 5 moderate 3xweek 30 minutes Week 6 moderate 4xweek 30 minutes Week 7 moderate 5xweek 30 minutes Week 8 moderate 5xweek 30 minutes
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