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

NCT05846334 | Recruiting

• 1 other identifier: 22-11015-BO
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months, after intervention

Secondary Outcomes (12)

• Health-related quality of life

  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

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

• Changes in functional capacity

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

• Blood pressure

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

• Heart rate

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

Other Outcomes (5)

• Treatment satisfaction

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

• Usability

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

• Predictors of usage behavior

  Baseline, after 3 months, after 4 months, after 6 months, after 9 months, after 15 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Device: mindfulHeart

Control group

NO INTERVENTION

Interventions

mindfulHeart 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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• Universität Duisburg-Essen: collaborator

Study Sites (1)

Westdeutsches Herz- und Gefäßzentrum, Klinik für Kardiologie und Angiologie

Essen, 45147, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 37715203 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Julia Lortz, MD

  University of Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Lortz, PD Dr.

CONTACT

+49 201 723; julia.lortz@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication
• Access Criteria: contact PI

Locations

DE (1)