Kardia - A Smartphone-based Care Model for Outpatient Cardiac Rehabilitation

NCT03415841 | Unknown DMC

• 1 other identifier: Kardia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post MI

Keywords

Post MI; Cardiac Rehabilitation; Wearable Devices; Smartphone-based Program

Outcome Measures

Primary Outcomes (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)

  9 months

Secondary Outcomes (3)

• Improvement in 6MWT

  9 Months

• Major Adverse Cardiovascular Events (MACE) and Hospitalizations

  12 months

• Improvement in quality of life

  9 months

Study Arms (2)

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.

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

Interventions

mHealth remote monitoring devices DEVICE

Blood Pressure and wearable vital signs monitor, Biovotion and "Kardia" mobile application

mHealth

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead
• Biofourmis Inc.: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 34741536 DERIVED

Study Officials

• Kelvin Wong, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelvin Wong

CONTACT

68502600; Kelvin_Wong@cgh.com.sg

Tang Xuan

CONTACT

68502923; Xuan_Tang@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: January 30, 2018
• Study Start: February 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: March 31, 2020
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)