Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation

Tan Tock Seng Hospital

Status: Unknown

Conditions: Cardiac Disease

Treatments: Other: Conventional Cardiac Rehab Classes; Device: Heart Track

Study type: Interventional

Funder types: Other

Identifiers

NCT04074057

2018/00977

Details and patient eligibility

About

n Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved.

Full description

In Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved. The key components of "Heart-Track" are: 1. Exercise principles based on international guidelines 2. Gamification; 3. Continuous heart rate monitoring; 4. Adaptation to local context. As Heart-track is the first of its kind, being designed for use in the local context, findings from research is important in determining its efficacy when compared to traditional cardiac rehabilitation.

Enrollment: 34 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 21-65 years old
2. Underwent coronary revascularisation follow AMI
3. Language literacy English or Mandarin
4. Owns a smart phone
5. Normal physiological response during exercise testing
6. Low or moderate risk following risk stratification.

Exclusion criteria

1. Medically unfit for exercise
2. Post op complication
3. High risk following risk stratification
4. Cognitive impaired

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

34 participants in 2 patient groups

Control arm

Other group

Description:

the control group will undergo a conventional weekly CR programme lasting 8-12 sessions. Components of each session will include warm up, aerobic training, resistance exercises and cool down. Patients are encouraged to continue their home exercises, exercising another 2 times a week at home and record down using an activity diary. The importance of CR programme and exercise advice will be explained and reinforced by the CR Physiotherapist. The submaximal exercise test and a body composition analysis will be repeated on the final assessment. Every week research coordinator will call the subject to remind them to exercise.

Treatment:

Other: Conventional Cardiac Rehab Classes

Intervention arm

Other group

Description:

During the initial assessment, the importance of CR and regular exercise will be explained and reinforced by CR physiotherapist. A research assistant will teach the patient how to use "Heart Track". The patient will then bring "Heart Track" home to continue their CR program. Patient will then undergo the whole CR programme to exercise for 3 times a day for 8-12 weeks using "Heart Track". Each "Heart Track" session will include warm up, aerobic training, resistance exercises and cool down (same as the traditional CR session). After 8-12 weeks, patient will be called back to the clinic by the research assistant to complete the final assessment (sub-maximal exercise test and a body composition analysis) with the blinded assessor. Every week research coordinator will call the subject to remind them to exercise.

Treatment:

Device: Heart Track