Clinical trial NCT05713565: A Digital Care Solution for Coronary Artery Disease Patients
Official title: A Randomized-controlled Trial Evaluating a Digital Care Solution (Sidekick, SK-121) for Coronary Artery Disease Patients at Landspítali University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
digital application
lifestyle change
remote monitoring
clinical outcome
quality of life
Lead sponsor: Sidekick Health
Sponsor class: INDUSTRY
Collaborators: name: Landspitali University Hospital
First posted: 2023-02-06
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center prospective randomized open blinded end-point (PROBE)
Primary purpose: TREATMENT

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.

Detailed description: Cardiovascular disease (CVD) is the leading cause of death worldwide, with an estimated number of 17.9 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 world's 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 Health's 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 patient's 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 Health's CAD digital program in combination with SoC compared to SoC alone.

Eligibility criteria: Inclusion Criteria:

* Adults diagnosed with coronary artery disease
* Fluent in verbal and written Icelandic
* Capacity to give informed consent
* Capacity to operate a smartphone

Exclusion Criteria:

* Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
* Not able or willing to comply with study intervention/scheduled measures and visits
* Having another serious medical condition (e.g., cancer, endocarditis, heart failure (EF\<40%), history of cardiac arrest)
* Active alcohol or drug abusers

Primary outcomes:
measure: Risk of recurrent Coronary Artery Disease
timeFrame: 12 months
Secondary outcomes:
measure: CAD-specific health status
timeFrame: 12 months
measure: Burden of Coronary Artery Disease
timeFrame: 12 months
measure: Medication adherence
timeFrame: 12 months
measure: Patients self-care and disease knowledge
timeFrame: 12 months
measure: Smoking status
timeFrame: 12 months
measure: Depression, anxiety, and stress levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Landspítali University Hospital
Study officials:
affiliation: National University Hospital of Iceland & University of Iceland
name: David O Arnar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: