A prospective, randomized, controlled, multicentre trial for secondary prevention in patients with chronic coronary syndrome using a smartphone application for digital therapy: the CHANGE study protocol.

Autor:	Düsing P; Department of Medicine II, Heart Center, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany., Eckardt I; Department of Medicine II, Heart Center, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany., Schirmer SH; Kardiopraxis Schirmer, Am Altenhof 8, 67655 Kaiserslautern, Germany., Sinning JM; Department of Cardiology, St. Vinzenz Hospital Cologne, Mehrheimer Str. 221-223, 50733 Cologne, Germany., Werner N; Medical Department III, Heart Center Trier, Krankenhaus der Barmherzigen Brüder, Nordallee 1, 54292 Trier, Germany., Bönner F; Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty of Heinrich Heine University, University Hospital Düsseldorf, Moorenstr 5, 40225 Düsseldorf, Germany., Krogmann A; Kardio-Lev, Kardiologische Gemeinschaftspraxis Dr. P. Son, Dr. M. Päsler, Dr. A. Krogmann, Friedrich-Ebert-Str. 17, 51373 Leverkusen, Germany., Schäfer S; Praxis Rheingalerie Rodenkirchen, Hauptstr 39-41, 50996 Cologne, Germany., Sedaghat A; Rhein-Ahr-Cardio, Praxis für Kardiologie, Wilhelmstr 14, 53474 Bad Neuenahr-Ahrweiler, Germany., Müller C; Kardio Bonn, Gemeinschaftspraxis Dr. La Rosée & Prof. Müller, Baumschulallee 1, 53115 Bonn, Germany., Nickenig G; Department of Medicine II, Heart Center, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany., Zietzer A; Department of Medicine II, Heart Center, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany.
Jazyk:	angličtina
Zdroj:	European heart journal. Digital health [Eur Heart J Digit Health] 2023 Feb 15; Vol. 4 (3), pp. 207-215. Date of Electronic Publication: 2023 Feb 15 (Print Publication: 2023).
DOI:	10.1093/ehjdh/ztad012
Abstrakt:	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. Competing Interests: Conflict of interest: A.Z. received a lecture fee from Vantis GmbH on one occasion. The authors declare no conflicts of interest. The authors are not employees or beneficiaries of the Vantis GmbH. (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
Databáze:	MEDLINE
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