Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-03-27
Brief Title:
mHealth Intervention to Reduce Perceived Stress in Patients With Ischemic Heart Disease
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
A mHealth Intervention to Reduce Perceived Stress in Patients With Ischemic Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mStress-IHD
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 eg 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 andor behavioral therapy or to other stress reducing interventions eg 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 247 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
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 andor behavioral therapy or to other stress reducing interventions eg 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 247 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None