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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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
  • Changi General Hospital

    Singapore, 529889

    Kelvin Wong, MD, 67881396, kelvin_wong@cgh.com.sg

    Recruiting

Other trials in Singapore

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 groups in NCT03415841
Study groupRoleWhat they receive
mHealthExperimental50 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
ControlNo interventionThe 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.

  1. 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)
  1. 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

  2. Major Adverse Cardiovascular Events (MACE) and Hospitalizations

    Reduction in MACE and Hospitalization

    Measured: 12 months

  3. 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.

  1. First posted30 Jan 2018
  2. Study start1 Feb 2018
  3. Primary completion30 Nov 2019 (estimated)
  4. Study completion31 Mar 2020 (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
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)
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

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.

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