A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention “mStress-IHD” trial

Lortz, Julia; Rassaf, Tienush; Jansen, Christoph; Knuschke, Ramtin; Schweda, Adam; Schnaubert, Lenka; Rammos, Christos; Köberlein-Neu, Juliane; Skoda, Eva-Maria; Teufel, Martin; Bäuerle, Alexander

Abstract

Background
Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention “mindfulHeart” in terms of reducing stress in patients with IHD.

Methods and analysis
This randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post-treatment (T1), and four follow-ups at months 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use of an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), and the participants’ pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression, and descriptive approaches will be performed for secondary analyses.

Ethics
The Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22–11,015-BO).

Trial registration
ClinicalTrials NCT05846334. Release 26.04.2023.

Citation

Lortz, J., Rassaf, T., Jansen, C., Knuschke, R., Schweda, A., Schnaubert, L., Rammos, C., Köberlein-Neu, J., Skoda, E.-M., Teufel, M., & Bäuerle, A. (2023). A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention “mStress-IHD” trial. Trials, 24, Article 592. https://doi.org/10.1186/s13063-023-07618-0

• Journal Article Type: Article
• Acceptance Date: Sep 1, 2023
• Online Publication Date: Sep 15, 2023
• Publication Date: 2023
• Deposit Date: Sep 20, 2023
• Publicly Available Date: Sep 20, 2023
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 24
• Article Number: 592
• DOI: https://doi.org/10.1186/s13063-023-07618-0
• Keywords: Humans, Cardiovascular Diseases, Myocardial Ischemia, Stress, Psychological, Quality of Life, Patients, Randomized Controlled Trials as Topic
• Public URL: https://nottingham-repository.worktribe.com/output/25363986
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07618-0
• PMID: 37715203