跳至主要内容
临床试验/NCT05713565
NCT05713565已完成不适用

A Randomized-controlled Trial Evaluating a Digital Care Solution (Sidekick, SK-121) for Coronary Artery Disease Patients at Landspítali University Hospital

Sidekick Health2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
201
试验地点
2
主要终点
Risk of recurrent Coronary Artery Disease

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will be blinded for group assignment at the 6-, and 12-month follow-up visit.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Risk of recurrent Coronary Artery Disease

时间窗: 12 months

Difference in change in total score of the Second Manifestations of ARTerial disease (SMART) risk score between the intervention and control groups. The SMART Risk Score is based on 13 demographic and clinical parameters, the resulting SMART Risk Scores range from 0 to 100%, with a lower score representing a lower risk.

次要结局

  • CAD-specific health status(12 months)
  • Smoking status(12 months)
  • Patients self-care and disease knowledge(12 months)
  • Burden of Coronary Artery Disease(12 months)
  • Medication adherence(12 months)
  • Depression, anxiety, and stress levels(12 months)

研究者

发起方
Sidekick Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

A Digital Care Solution for Coronary Artery Disease... | 临床试验