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

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.

Effect of visual presentation of atherosclerotic carotid plaque on adherence to secondary preventive therapy using mHealth technologies (PreventiPlaque app): Study protocol for a randomized controlled trial.

Background: Cardiovascular disease is the major cause of death worldwide. Although knowledge regarding diagnosing and treating cardiovascular disease has increased dramatically, secondary prevention remains insufficiently implemented due to failure among affected individuals to adhere to guideline recommendations. This has continued to lead to high morbidity and mortality rates. Involving patients in their healthcare and facilitating their active roles in their chronic disease management is an opportunity to meet the needs of the increasing number of cardiovascular patients. However, simple recall of advice regarding a more preventive lifestyle does not affect sustainable behavioral lifestyle changes. We investigate the effect of plaque visualization combined with low-threshold daily lifestyle tasks using the smartphone app PreventiPlaque to evaluate change in cardiovascular risk profile. Methods: and study design: This randomized, controlled clinical trial includes 240 participants with ultrasound evidence of atherosclerotic plaque in one or both carotid arteries, defined as focal thickening of the vessel wall measuring 50% more than the regular vessel wall. A criterion for participation is access to a smartphone suitable for app usage. The participants are randomly assigned to an intervention or a control group. While both groups receive the standard of care, the intervention group has additional access to the PreventiPlaque app during the 12-month follow-up. The app includes daily tasks that promote a healthier lifestyle in the areas of smoking cessation, medication adherence, physical activity, and diet. The impact of plaque visualization and app use on the change in cardiovascular risk profile is assessed by SCORE2. Feasibility and effectiveness of the PreventiPlaque app are evaluated using standardized and validated measures for patient feedback. Ethics and dissemination: This clinical trial is approved by the ethics committee of the University of Duisburg-Essen (Germany). Study results will be disseminated at conferences and in peer-reviewed journals. Information regarding the PreventiPlaque app is available via print media, social media channels, and on the authors' websites.

The Cognitive-Affective-Social Theory of Learning in digital Environments (CASTLE).

For a long time, research on individuals learning in digital environments was primarily based on cognitive-oriented theories. This paper aims at providing evidence that social processes affect individual learning with digital materials. Based on these theories and empirical results, a social-processes-augmented theory is suggested: the Cognitive-Affective-Social Theory of Learning in digital Environments (CASTLE). This CASTLE postulates that social cues in digital materials activate social schemata in learners leading to enhanced (para-)social, motivational, emotional, and metacognitive processes. To substantiate this theory, socio-cognitive theories are used, which predict social influences on learning with digital materials. Besides, previous empirical findings are presented assuming that with a rising number of social cues in digital materials, the influence of social processes increases. Finally, consequences regarding the design of digital learning media are discussed.

What interdependence can tell us about collaborative learning: a statistical and psychological perspective.

When learning collaboratively, learners interact and communicate transactively. Interventions to foster collaborative learning frequently target such interactive processes and thus may drastically change how learners engage with and thus influence each other. One statistical phenomenon related to collaborative learning is the interdependence of data gained from learners collaborating. Often viewed as a mere statistical phenomenon, on a conceptual level, statistical interdependence is a similarity between learners mainly resulting from the mutual influence learners have on each other while collaborating and is thus closely related to collaborative practices. In this paper, we report data of an exemplary study (N = 82) to illustrate how information on interdependence and within- and between-dyad variance may add to data interpretation. The study examined how providing metacognitive group awareness information during collaboration affects individual learning outcomes. We found indications that the information fosters knowledge gain, but not confidence. Surprisingly, the data revealed different levels of interdependence between conditions, which led us to assume interdependence to be part of the treatment effect resulting from differential collaboration processes. We discuss reasons and implications of varying levels of statistical interdependence and their impact on inferential and descriptive statistics.