Clinical trial NCT05846334: MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease
Official title: A MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: Universität Duisburg-Essen
First posted: 2023-05-06
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and worsened cardiovascular outcome. The importance of stress management is now recognized in recent cardiovascular guidelines. However, effective stress management intervention 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.

Detailed description: Chronic stress occurs over an extended period, from months to years, and can result in several adverse health consequences. The relationship between chronic stress and cardiovascular diseases continues to be subject of extensive research. Recent large studies have shown that chronic stress is linked to heightened risk for cardiovascular diseases (CVD), leading to its recognition in current clinical guidelines. Chronic stress was demonstrated as risk factor for the development, but also for the progression of CVD, and research has found associations between stress measurements and traditional cardiovascular risk factors. Stress is also considered as relevant player in the pathophysiological cascade of coronary atherosclerosis formation (e.g., inflammatory response, endothelial dysfunction, platelet aggregation) until the development of clinical apparent ischemic heart disease (IHD). Measures of stress have been associated with the onset and progression of further cardiovascular disorders, like coronary calcification, atrial fibrillation, and stroke. In patients with IHD, stress has also been implicated as an acute trigger of myocardial ischemia and infarction, malignant arrhythmias, and sudden cardiac death.

Although the body of evidence examining the stress-IHD connection is growing, there continues to be a lack of recognition of this association in clinical practice and of effective and scalable interventions. Desirable would be the sustainable integration of targeted therapy in cardiology practice that involves screening for stress, referral to psychological, and/or behavioral therapy or to other stress reducing interventions (e.g. meditation, holistic self-care programs, or other complementary approaches). Although ongoing group support and concomitant coaching in other lifestyle-related fields such as diet and exercise are conductive to long-term adherence, the establishment of area-wide structured stress management programs is resource-intensive and currently not available.

A potential solution to cost-prohibitive stress reduction programs is the development of easily disseminated eHealth intervention, which can be effective and scalable, and easier to implement in the context of a busy clinical practice. The term "eHealth" encompasses a wide range of electronic solutions, such as mobile phones (mHealth) and computers that can enhance and broaden the scope of medical care.

Especially mHealth interventions are perceived to offer several advantages that may overcome some of the limitations of face-to-face approaches, including anonymity, 24/7 availability, reduced costs in terms of traveling to courses for both participants and instructors, high scalability, and a low access threshold. Enabling participants to be reached earlier than in classical face-to-face trainings, such interventions may have the potential to prevent even the onset of more severe chronic stress or mental health problems. The effectiveness of eHealth interventions for stress reduction was shown in a recent meta-analysis.

The link between stress and increased mortality and morbidity in CVD is obvious and includes also an undeniable reduction in health-related quality of life (HRQoL). This lead to the fact that the search for novel therapeutic strategies is inevitable. Therefore, the investigators aim in the current study to evaluate the efficacy and cost-effectiveness of the digital stress management intervention 'mindfulHeart' in terms of sustainable stress reduction in the target population.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of IHD
* elevated perceived stress for at least 4 weeks
* own an Internet-enabled smartphone and know how to use it
* have provided written informed consent

Exclusion Criteria:

* Participants who have severe cognitive impairment and/or communication difficulties that may affect their ability to participate in the study
* psychiatric or medical conditions that require alternative treatment
* no private internet access

Primary outcomes:
measure: combined global stress measure
timeFrame: 3 months, after intervention
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Disease-specific effect of angina on patients' physical function and quality of life
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Changes in functional capacity
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Blood pressure
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Heart rate
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Self-efficacy
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: combined global stress measure
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Depression symptoms (BDI-II)
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Anxiety symptoms (STAI)
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: PROMIS-Anger Scale
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: GHQ
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Perceived Stress Scale
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Other outcomes:
measure: Treatment satisfaction
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Usability
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Predictors of usage behavior
timeFrame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
measure: Cost-effectiveness
timeFrame: after 15 months
measure: Cost-utility
timeFrame: after 15 months
Locations:
city: Essen
country: Germany
facility: Westdeutsches Herz- und Gefäßzentrum, Klinik für Kardiologie und Angiologie
Study officials:
affiliation: University of Duisburg-Essen
name: Julia Lortz, MD
role: PRINCIPAL_INVESTIGATOR
References: