MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease

NCT ID: NCT05846334

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-05-01

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

mindfulHeart

Intervention Type: DEVICE

'mindfulHeart' is an interactive, self-guided and patient-oriented mHealth intervention for the reduction of stress in patients with IHD and includes automated feedback via visualization of changes in patient reported outcome measures (PROMs).

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mindfulHeart

'mindfulHeart' is an interactive, self-guided and patient-oriented mHealth intervention for the reduction of stress in patients with IHD and includes automated feedback via visualization of changes in patient reported outcome measures (PROMs).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Lortz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Duisburg-Essen

Locations

Westdeutsches Herz- und Gefäßzentrum, Klinik für Kardiologie und Angiologie

Essen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Julia Lortz, PD Dr.

Role: CONTACT

Phone: +49 201 723

Email: julia.lortz@uk-essen.de

Facility Contacts

Julia Lortz, PD Dr.

Role: primary

References

Lortz J, Rassaf T, Jansen C, Knuschke R, Schweda A, Schnaubert L, Rammos C, Koberlein-Neu J, Skoda EM, Teufel M, Bauerle A. 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. 2023 Sep 15;24(1):592. doi: 10.1186/s13063-023-07618-0.

Reference Type: DERIVED

PMID: 37715203 (View on PubMed)

Other Identifiers

22-11015-BO

Identifier Type: -

Identifier Source: org_study_id