Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05713565
Status:
RECRUITING
Last Update Posted:
2023-02-24
First Post:
2023-01-25
Brief Title:
A Digital Care Solution for Coronary Artery Disease Patients
Sponsor:
Sidekick Health
Organization:
Sidekick Health
Study Overview
Official Title:
A Randomized-controlled Trial Evaluating a Digital Care Solution Sidekick SK-121 for Coronary Artery Disease Patients at Landspítali University Hospital
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
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:
This is a single center randomized clinical trial RCT recruiting 200 patients with coronary artery disease CAD who are currently receiving standard care treatment at the cardiology department of Landspítali University Hospital in Reykjavik Iceland
The RCT will determine whether an interactive health app that supports lifestyle changes can positively impact disease progression and quality of life of CAD patients Patients will be randomized to receive either the standard of care SoC alone or SoC with the addition of the digital app The digital app will include remote patient monitoring and a patient support program specific for CAD patients
The investigators will study the impact of the digitally delivered lifestyle intervention and remote monitoring on disease progression and on the patients quality of life
The RCT will determine whether an interactive health app that supports lifestyle changes can positively impact disease progression and quality of life of CAD patients Patients will be randomized to receive either the standard of care SoC alone or SoC with the addition of the digital app The digital app will include remote patient monitoring and a patient support program specific for CAD patients
The investigators will study the impact of the digitally delivered lifestyle intervention and remote monitoring on disease progression and on the patients quality of life
Detailed Description:
Cardiovascular disease CVD is the leading cause of death worldwide with an estimated number of 179 million deaths each year Coronary artery disease CAD is the most common form of CVD and is caused by plaque buildup atherosclerosis in the walls of the coronary arteries that supply blood to the heart The plaques consist of deposits of cholesterol fat calcium and other substances Atherosclerosis of the coronary arteries reduces blood flow to the heart and can eventually result in a myocardial infarction
Lifestyle-related risk factors are known to play an important role in the development of CAD and CVD in general and many of these risk factors are modifiable The most important modifiable cardiovascular risk factors are an unhealthy diet physical inactivity smoking use and excessive use of alcohol Improvements in these modifiable risk factors can significantly lower the risk of recurrent events in CVD patients
Many clinical trials have shown that lifestyle interventions focused on for instance improving diet physical activity weight and waist circumference reduce cardiovascular risk scores Also recurrence of cardiac events can be reduced by lifestyle interventions as smoking cessation was associated with 43 reduction of recurrent myocardial infarction and regular exercise and diet modifications reduced the risk of recurrent myocardial infarction by 48 Exercise intervention reduced mortality by 27 and diet intervention reduced mortality by 26 While on the other hand reduced physical activity has been shown to increase the risk of cardiac death in CAD patients
Lifestyle modification has not only been shown to improve quality of life but is also cost-effective Lifestyle intervention is recommended by clinical guidelines but a gap exists between recommendations and what is being implemented in clinical practice Finding simple ways to incorporate lifestyle intervention to standard CAD care could undoubtedly improve patient outcomes and the disease burden
Because of the widespread ownership of smartphones digital applications hold promise for providing lifestyle modification support to large numbers of people in a format that is readily accessible at almost any time Approximately two-thirds of the worlds population owns a smartphone and in 2019 there were 204 billion app downloads Considering the evidence the use of digital applications seems supported However currently there is still limited data to draw from on the effectiveness of digitally delivered remote monitoring and patient support programs for CAD patients As a result more data is needed
In this study Sidekick Healths newly developed digital care solution including remote patient monitoring RPM and a patient support program PSP specifically developed for CAD patients will be tested Comparing the effect of adding a digital solution to the standard of care SoC this study will investigate the impact of a holistic digitally delivered lifestyle intervention and remote monitoring on disease progression and on the CAD patients quality of life
The aim of this study is to test the effectiveness of improving clinical outcomes and quality of life by using the Sidekick Healths CAD digital program in combination with SoC compared to SoC alone
Lifestyle-related risk factors are known to play an important role in the development of CAD and CVD in general and many of these risk factors are modifiable The most important modifiable cardiovascular risk factors are an unhealthy diet physical inactivity smoking use and excessive use of alcohol Improvements in these modifiable risk factors can significantly lower the risk of recurrent events in CVD patients
Many clinical trials have shown that lifestyle interventions focused on for instance improving diet physical activity weight and waist circumference reduce cardiovascular risk scores Also recurrence of cardiac events can be reduced by lifestyle interventions as smoking cessation was associated with 43 reduction of recurrent myocardial infarction and regular exercise and diet modifications reduced the risk of recurrent myocardial infarction by 48 Exercise intervention reduced mortality by 27 and diet intervention reduced mortality by 26 While on the other hand reduced physical activity has been shown to increase the risk of cardiac death in CAD patients
Lifestyle modification has not only been shown to improve quality of life but is also cost-effective Lifestyle intervention is recommended by clinical guidelines but a gap exists between recommendations and what is being implemented in clinical practice Finding simple ways to incorporate lifestyle intervention to standard CAD care could undoubtedly improve patient outcomes and the disease burden
Because of the widespread ownership of smartphones digital applications hold promise for providing lifestyle modification support to large numbers of people in a format that is readily accessible at almost any time Approximately two-thirds of the worlds population owns a smartphone and in 2019 there were 204 billion app downloads Considering the evidence the use of digital applications seems supported However currently there is still limited data to draw from on the effectiveness of digitally delivered remote monitoring and patient support programs for CAD patients As a result more data is needed
In this study Sidekick Healths newly developed digital care solution including remote patient monitoring RPM and a patient support program PSP specifically developed for CAD patients will be tested Comparing the effect of adding a digital solution to the standard of care SoC this study will investigate the impact of a holistic digitally delivered lifestyle intervention and remote monitoring on disease progression and on the CAD patients quality of life
The aim of this study is to test the effectiveness of improving clinical outcomes and quality of life by using the Sidekick Healths CAD digital program in combination with SoC compared to SoC alone
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