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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
A prospective, randomized, controlled, multicentre trial for secondary prevention in patients with chronic coronary
Philip Düsing1, Irina Eckardt1, Stephan H Schirmer2
1Department of Medicine II, Heart Center, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany.
Insights
The CHANGE study evaluates a smartphone app for improving secondary prevention adherence and quality of life in chronic coronary syndrome (CCS) patients. This digital tool aims to optimize care for individuals with this leading cause of global mortality.
Area of Science:
- Cardiology
- Digital Health
- Preventive Medicine
Background:
- Coronary artery disease (CAD), now termed chronic coronary syndrome (CCS), is a major global cause of mortality.
- Despite advances, CCS patients face high morbidity and mortality rates.
- Optimal secondary prevention is crucial, involving risk factor modification and lifestyle changes.
Purpose of the Study:
- To investigate the efficacy of a smartphone application in enhancing secondary prevention adherence among CCS patients.
- To assess the impact of a digital health intervention on the quality of life (QoL) for individuals with CCS.
- To provide evidence for optimizing secondary prevention strategies in CCS management.
Main Methods:
- Prospective, randomized, controlled trial with 210 CCS patients across nine German centers.
- 1:1 allocation to either standard-of-care or standard-of-care plus the VantisTherapy* smartphone app.
- Outcomes measured at 0, 12, and 24 weeks, focusing on adherence to secondary prevention guidelines and QoL.
Main Results:
- The study is ongoing, with recruitment initiated in July 2022.
- Primary outcomes focus on adherence and QoL, with data collected over 24 weeks.
- The trial is registered under DRKS00028081.
Conclusions:
- The CHANGE study will determine if a smartphone-guided app improves adherence and QoL in CCS patients compared to standard care.
- This research explores the potential of digital tools in managing chronic conditions like CCS.
- Findings may inform future digital health strategies for cardiovascular disease prevention.
Aims:
Coronary artery disease (CAD) remains the leading cause of death worldwide. 'Stable' CAD is a chronic progressive condition, which recent European guidelines recommend referring to as 'chronic coronary syndrome' (CCS). Despite therapeutic advances, morbidity and mortality among patients with CCS remain high. Optimal secondary prevention in patients with CCS includes optimization of modifiable risk factors with behavioural changes and pharmacological therapy. The CHANGE study aims to provide evidence for optimization of secondary prevention in CCS patients by using a smartphone application (app).
Methods And Results:
The CHANGE study is designed as a prospective, randomized, controlled trial with a 1:1 allocation ratio, which is currently performed in nine centres in Germany in a parallel group design. 210 patients with CCS will be randomly allocated either to the control group (standard-of-care) or to the intervention group, who will be provided the VantisTherapy* app in addition to standard-of-care to incorporate secondary prevention into their daily life. The study will be performed in an open design. Outcomes will be assessed using objective data from three in-person visits (0, 12, and 24 weeks). Primary outcomes will involve adherence to secondary prevention recommendations and quality of life (QoL). The recruitment process started in July 2022.
Conclusion:
The CHANGE study will investigate whether a smartphone-guided secondary prevention app, combined with a monitor function compared with standard-of-care, has beneficial effects on overall adherence to secondary prevention guidelines and QoL in patients with CCS.
Trial Registration:
The study is listed at the German study registry (DRKS) under the registered number DRKS00028081.
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