Post MINCT03415841
Kardia - A Smartphone-based Care Model for Outpatient Cardiac Rehabilitation
A study testing mHealth remote monitoring devices in people with Post MI, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Post MI
- What is being tested?
- mHealth remote monitoring devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2018to 31 Mar 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-85 years
- Willing and able to provide informed consent
- New onset of Post ST elevation and non-ST elevation myocardial infarction/staged PCI/acute coronary syndrome/unstable angina
- Own and able to operate App on smartphone
Who cannot join
- History of ventricular fibrillation not in the setting of acute myocardial infarction
- Documented sustained ventricular or supraventricular arrhythmia
- Unstable angina
- Awaiting staged revascularization
- Inability to perform 6MWT
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Kelvin Wong, MD, 67881396, kelvin_wong@cgh.com.sg
About this study
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 content/tasks, 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 (e.g. dietary habits, stress levels, physical activity) assessed using questionnaires, major adverse cardiovascular events (MACE), modification of cardiovascular risk profiles (i.e. LDL, BP, BMI, HbA1c, etc) and medicine compliance.
Read the 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 American/European 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 content/tasks, 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, i.e. 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 Frequency/Duration Patient actions Week 1 light 3x/week; 10 minutes Exercise diary Week 2 light 3x/week; 20 minutes Week 3 light 3x/week; 30 minutes Week 4 moderate 3x/week; 15 minutes Week 5 moderate 3x/week; 30 minutes Week 6 moderate 4x/week; 30 minutes Week 7 moderate 5x/week; 30 minutes Week 8 moderate 5x/week; 30 minutes
- Conditions
- Post MI
- Being tested
- mHealth remote monitoring devices
- Keywords
- Post MI, Cardiac Rehabilitation, Wearable Devices, Smartphone-based Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth remote monitoring devicesDevice
Blood Pressure and wearable vital signs monitor, Biovotion and "Kardia" mobile application
| Study group | Role | What they receive |
|---|---|---|
| mHealth | Experimental | 50 patients who are randomized to the intervention group (mHealth remote monitoring devices) 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. Receives: Device: mHealth remote monitoring devices |
| Control | No intervention | The control group (50 patients) will just be monitored at fixed intervals in the outpatient Cardiology clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance and adherence to the "Kardia" program
Compliance to smart phone based cardiac rehabilitation program - Uploading of completed data (BP, activity) to web portal. Compliance is defined as taking at least 1 BP per day and wearing the Biovotion for >10 hours per day.
(90% compliance in intervention group would be considered acceptable)
Measured: 9 months
Secondary outcomes (3)
Improvement in 6MWT
6MWT at baseline (within 2 weeks upon discharge) months 3 (+/- 2 months) and 9 (+/- 3 months) will be analysed and compared
Measured: 9 Months
Major Adverse Cardiovascular Events (MACE) and Hospitalizations
Reduction in MACE and Hospitalization
Measured: 12 months
Improvement in quality of life
EQ5D questionaire
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Feb 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post MIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biofourmis Inc.
- Responsible party
- Sponsor
- Investigators
- Kelvin Wong, MD, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415841
- Sponsor's protocol ID
- Kardia
- Status last verified
- May 2019
- First submitted
- 24 Oct 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
PubMed 34741536
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kardia - A Smartphone-based Care Model for Outpatient Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT03415841
- Acronym / sponsor ID
- Kardia
- Conditions
- Post MI
- Keywords
- Post MI, Cardiac Rehabilitation, Wearable Devices, Smartphone-based Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Biofourmis Inc.
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 content/tasks, 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 (e.g. dietary habits, stress levels, physical activity) assessed using questionnaires, major adverse cardiovascular events (MACE), modification of cardiovascular risk profiles (i.e. 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 American/European 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 content/tasks, 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, i.e. 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 Frequency/Duration Patient actions Week 1 light 3x/week; 10 minutes Exercise diary Week 2 light 3x/week; 20 minutes Week 3 light 3x/week; 30 minutes Week 4 moderate 3x/week; 15 minutes Week 5 moderate 3x/week; 30 minutes Week 6 moderate 4x/week; 30 minutes Week 7 moderate 5x/week; 30 minutes Week 8 moderate 5x/week; 30 minutes
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| mHealth | Experimental | Device: mHealth remote monitoring devices50 patients who are randomized to the intervention group (mHealth remote monitoring devices) 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. |
| Control | No intervention | –The control group (50 patients) will just be monitored at fixed intervals in the outpatient Cardiology clinics |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21-85 years
- Willing and able to provide informed consent
- New onset of Post ST elevation and non-ST elevation myocardial infarction/staged PCI/acute coronary syndrome/unstable angina
- Own and able to operate App on smartphone
Key exclusion criteria (5 listed)
- History of ventricular fibrillation not in the setting of acute myocardial infarction
- Documented sustained ventricular or supraventricular arrhythmia
- Unstable angina
- Awaiting staged revascularization
- Inability to perform 6MWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth remote monitoring devicesBlood Pressure and wearable vital signs monitor, Biovotion and "Kardia" mobile application | Device | mHealth |
Primary outcome
Compliance and adherence to the "Kardia" program
Time frame: 9 months
Compliance to smart phone based cardiac rehabilitation program - Uploading of completed data (BP, activity) to web portal. Compliance is defined as taking at least 1 BP per day and wearing the Biovotion for >10 hours per day. (90% compliance in intervention group would be considered acceptable)
3 secondary outcomes
Improvement in 6MWT
Time frame: 9 Months
Major Adverse Cardiovascular Events (MACE) and Hospitalizations
Time frame: 12 months
Improvement in quality of life
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Derived from this study: PubMed 34741536Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelvin Wong, MD principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth remote monitoring devices in people with Post MI, run by Changi General Hospital at 1 site 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 4 inclusion and 5 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kelvin Wong (68502600, Kelvin_Wong@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance and adherence to the "Kardia" program (time frame: 9 months). 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 NCT03415841, 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 7 May 2019.