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A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the
Julia Lortz1, Tienush Rassaf2, Christoph Jansen3,4
1Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Duisburg-Essen, Essen, 45147, Germany. julia.lortz@uk-essen.de.
Insights
This study evaluates the "mindfulHeart" mobile health intervention for reducing stress in ischemic heart disease patients. The trial aims to determine its effectiveness and cost-efficiency for improving cardiovascular outcomes.
Area of Science:
- Cardiology
- Digital Health
- Psychosomatic Medicine
Background:
- Stress is common in ischemic heart disease (IHD) patients, negatively impacting quality of life and cardiovascular outcomes.
- Current guidelines recognize stress management's importance, but effective interventions are not standard clinical practice.
- Mobile health (mHealth) offers a scalable and cost-effective solution for delivering stress management interventions.
Purpose of the Study:
- To assess the efficiency of the "mindfulHeart" mHealth intervention in reducing stress among IHD patients.
- To evaluate the cost-effectiveness of the "mindfulHeart" intervention.
- To provide a scalable digital health solution for stress management in cardiovascular disease.
Main Methods:
- A randomized controlled trial with two parallel arms and six assessment time points (baseline to 12-month follow-up).
- Inclusion criteria: confirmed IHD diagnosis, high perceived stress, and smartphone ownership.
- Primary analysis using ANCOVA on intention-to-treat population with imputed missing data.
Main Results:
- The study is designed to determine the primary outcome of stress reduction at post-treatment (T1).
- Secondary analyses will explore various statistical approaches to evaluate intervention effects.
- The trial is powered to detect significant differences between the intervention and control groups.
Conclusions:
- The "mindfulHeart" mHealth intervention has the potential to be an effective and cost-efficient tool for stress reduction in IHD patients.
- Successful implementation could improve clinical routine for cardiovascular disease management.
- This trial will provide crucial data on the efficacy of digital health solutions for chronic disease management.
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.
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