Ischemic Heart DiseasemStress-IHDNCT05846334
MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease
A study testing mindfulHeart in people with Ischemic Heart Disease, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- mindfulHeart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Westdeutsches Herz- und Gefäßzentrum, Klinik für Kardiologie und Angiologie
Essen, 45147
Julia Lortz, PD Dr., 0049 201 723 ext. 84995, julia.lortz@uk-essen.de
About this study
Official title: A MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease
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.
Read the 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
- Being tested
- mindfulHeart
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulHeartDevice
'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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: mindfulHeart |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined global stress measure
The outcome is based on a published RCT in Circulation by Blumenthal et al. [34]. A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2. (see also NCT00981253)
Measured: 3 months, after intervention
Secondary outcomes (12)
Health-related quality of life
we will apply two instrument to measure health-related quality of life. Namely the Short Form-36 health questionnaire and the European Quality of Life 5 Dimensions 5 Level survey (EQ-5D-5L) [36,37]. The SF-36 is an eight-dimensional scale consisting of 36 items. It assesses health-related quality of life based on physical, social, and psychological functioning, role behavior due to physical and psychological functional impairment, physical pain, general health perception, and vitality. The EQ-5D-5L consists of five health-related dimensions that can be assessed at five levels. In addition, the questionnaire contains a visual analog scale for assessing general health
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Disease-specific effect of angina on patients' physical function and quality of life
We will also include the Seattle Angina Questionnaire (SAQ). The 7-item version of the SAQ is a shortened version of the original 19-item SAQ and has been shown to be highly valid, reliable, and sensitive to clinical change. These ranges of SAQ scores are strongly and independently correlated with the risk of subsequent death, the risk of myocardial infarction, and health care costs
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Changes in functional capacity
changes in functional capacity will be recorded using the established 6-minute walk test
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Blood pressure
To evaluate the effect of the intervention on blood pressure , this parameters will be assessed with the average of three consecutive measurements at rest. The standard measurement approach was always performed in the same quiet room at a consistent controlled temperature and after a resting period of at least 20 minutes. The same examination sequence was maintained for all study subjects. To obtain reliable measurements, the patients were asked not to speak and to lie quietly during the entire measurement.
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Heart rate
To evaluate the effect of the intervention on heart rate , this parameters will be assessed with the average of three consecutive measurements at rest. The standard measurement approach was always performed in the same quiet room at a consistent controlled temperature and after a resting period of at least 20 minutes. The same examination sequence was maintained for all study subjects. To obtain reliable measurements, the patients were asked not to speak and to lie quietly during the entire measurement.
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Self-efficacy
To evaluate self-efficacy, we will utilize the Generalized Self-Efficacy Scale (GSES) in its German version [41]. The GSES is a self-administered questionnaire that measures an individual's optimistic self-beliefs and self-efficacy in dealing with challenging demands and stressful events in life. Each of the 10 items is rated on a 4-point Likert scale.
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
combined global stress measure
The outcome is based on a published RCT in Circulation by Blumenthal et al. [34]. A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2. (see also NCT00981253)
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Depression symptoms (BDI-II)
The BDI-II is a self-report questionnaire comprising 21 items that assess depression severity. Its reliability and validity have been established through various studies among diverse populations and cultural backgrounds. Higher scores indicates increased depression symptoms
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Anxiety symptoms (STAI)
The STAI is the most authoritative tool for assessing anxiety in adults, precisely distinguishing between transient "state anxiety" and persistent "trait anxiety". The STAI measures anxiety with 20 items and has a range of 20 to 80. A higher score indicates more pronounced anxiety
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
PROMIS-Anger Scale
The PROMIS Anger scale comprises eight items that evaluate various aspects of anger. Scores on the scale range from 8 to 40, with higher scores indicating greater levels of anger
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
GHQ
The GHQ assesses general distress and consists of 12 items. Respondents' scores range from 0 to 36, where higher scores correspond to increased distress
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Perceived Stress Scale
The Perceived Stress Scale-10 item version is a short tool for the assessment of how individuals perceive stress in their lives. The values range from 0 to 40. Higher values indicate higher perceived stress [46].
(l) In-treatment assessments: at the start of each intervention module (weekly), the following assessment instruments will be applied: Distress Thermometer (DT), Patient Health Questionnaire-4 (PHQ-4) and self-generated measures to assess coping skills and self-efficacy
Measured: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Duisburg-Essen
- Responsible party
- Sponsor
- Investigators
- Julia Lortz, MD, Principal investigator, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846334
- Sponsor's protocol ID
- 22-11015-BO
- Acronym
- mStress-IHD
- Status last verified
- May 2024
- First submitted
- 27 Mar 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37715203
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT05846334
- Acronym / sponsor ID
- mStress-IHD / 22-11015-BO
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Universität Duisburg-Essen
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: mindfulHeart |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Intervention group |
Primary outcome
combined global stress measure
Time frame: 3 months, after intervention
The outcome is based on a published RCT in Circulation by Blumenthal et al. [34]. A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2. (see also NCT00981253)
12 secondary outcomes
Health-related quality of life
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Disease-specific effect of angina on patients' physical function and quality of life
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Changes in functional capacity
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Blood pressure
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Heart rate
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Self-efficacy
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
combined global stress measure
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Depression symptoms (BDI-II)
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Anxiety symptoms (STAI)
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
PROMIS-Anger Scale
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
GHQ
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Perceived Stress Scale
Time frame: Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 37715203Lortz 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Lortz, MD principal investigator
University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulHeart in people with Ischemic Heart Disease, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Lortz, PD Dr. (+49 201 723 ext. 84995, julia.lortz@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combined global stress measure (time frame: 3 months, after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.