Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation

Cardiac Disease Clinical Trial

Official title:

Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation Compared to Traditional Centre-based, Therapist Driven Cardiac Rehabilitation for Patients Post Coronary Revascularisation : A Non-inferiority Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074057
• Other study ID #: 2018/00977
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2019
• Source: Tan Tock Seng Hospital
• Contact: Eng Chuan Neoh, Masters
• Phone: 91733222
• Email: eng_chuan_neoh[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Other:
• Conventional Cardiac Rehab Classes
conventional weekly CR programme lasting 8-12 sessions.

Device:
• Heart Track
Key components of "Heart-Track" are a heart rate sensor, a mobile app and a remote monitoring portal. The "Heart-Track" mobile app is synchronized/ connected to Polar heart rate sensor through bluetooth in order to provide continous heart rate monitoring when subjects are exercising. This is to ensure safety and exercise effectiveness.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walk test	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The MCID for 6MWD in patients with CAD after ACS was 25m.	through study completion, an average of 1 year
Primary	Body weight	Body weight will be assessed , record in kg	through study completion, an average of 1 year
Primary	Body Height	Body height will be assessed, record in meter	through study completion, an average of 1 year
Primary	Body Mass Index	Measure of body fat based on height and weight that applies to adult men and women. Calculated by using body weight and height (kg/m2)	through study completion, an average of 1 year
Primary	Body Fat Percentage	Assess using a bioelectrical impedance analysis (BIA) method, record in percentage %	through study completion, an average of 1 year
Primary	Skeletal muscle mass	Assess using a bioelectrical impedance analysis (BIA) method, record in kg	through study completion, an average of 1 year
Primary	Waist Hip Ratio	Assess using a bioelectrical impedance analysis (BIA) method	through study completion, an average of 1 year
Primary	Borg's RPE scale	Rating of perceived exertion (RPE) is a widely used and reliable indicator to monitor and guide exercise intensity. The scale allows individuals to subjectively rate their level of exertion during exercise or exercise testing. body fat,Skeletal muscle mass, Waist-hip ratio can be measured by using the body composition analysis machine. Borg scale 6-20, 6 is very very light and 20 is very very hard.	through study completion, an average of 1 year
Secondary	Self-Efficacy for Exercise Scale•	This scale is a self-report of exercise self-efficacy. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.	through study completion, an average of 1 year
Secondary	Health related QoL: MacNew myocardial infarction Quality of life questionnaire	The MacNew consists of 27 items which fall into three domains [a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale]. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs.; Scores are reported using a descriptive scale which are described as: "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time" and "none of the time"; The maximum possible score in any domain is 7 [high HRQL] and the minimum is 1 [poor HRQL]	through study completion, an average of 1 year
Secondary	Patient-reported survey on usability of Heart Track acceptability	Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. The survey form is a likert-scale ( Strongly agree to strongly disagree) survey that asking subjects about their feedback and satisfaction about the Heart Track hardware and software, and overall experience using Heart Track.	through study completion, an average of 1 year