Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04074057
Status:
UNKNOWN
Last Update Posted:
2019-08-29
First Post:
2019-08-20
Brief Title:
Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None