Evidence map›Paper›PMID 37715203›Full record

ArticleTrials2023

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention "mStress-IHD" trial.

Julia Lortz, Tienush Rassaf, Christoph Jansen, Ramtin Knuschke, Adam Schweda, Lenka Schnaubert, Christos Rammos, Juliane Köberlein-Neu, Eva-Maria Skoda, Martin Teufel and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05846334 (A MHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05846334 naunknown statusnot on this mapstarted 2024, after this paper: background citation

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

TypeinterventionalSponsorUniversity Hospital, EssenRan2024 to 2026Enrolled128ConditionsIschemic Heart DiseaseArmsmindfulHeart
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

Julia LortzDepartment of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Duisburg-Essen, Essen, 45147, Germany. julia.lortz@uk-essen.de.ORCID http://orcid.org/0000-0002-5798-3728
Tienush RassafDepartment of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Duisburg-Essen, Essen, 45147, Germany.
Christoph JansenClinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, LVR-University Hospital Essen, Essen, 45147, Germany.
Ramtin KnuschkeDepartment of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Duisburg-Essen, Essen, 45147, Germany.
Adam SchwedaClinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, LVR-University Hospital Essen, Essen, 45147, Germany.
Lenka SchnaubertLearning Sciences Research Institute, School of Education, University of Nottingham, Nottingham, NG8 1BB, UK.
Christos RammosDepartment of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Duisburg-Essen, Essen, 45147, Germany.
Juliane Köberlein-NeuSchumpeter School of Business and Economics, Center for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, 42119, Germany.
Eva-Maria SkodaClinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, LVR-University Hospital Essen, Essen, 45147, Germany.
Martin TeufelClinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, LVR-University Hospital Essen, Essen, 45147, Germany.
Alexander BäuerleClinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, LVR-University Hospital Essen, Essen, 45147, Germany.
University of Duisburg-Essen · DEWest German Heart and Vascular Center Essen · DEUniversity of Nottingham · GBUniversity of Wuppertal · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions 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. METHODS AND ANALYSIS: This randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post-treatment (T1), and four follow-ups at months 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use of an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), and the participants' pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression, and descriptive approaches will be performed for secondary analyses. ETHICS: The Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22-11,015-BO).

trial registrationClinicalTrials NCT05846334. Release 26.04.2023.

Indexed as

Cardiovascular DiseasesMyocardial IschemiaHumansPatientsQuality of LifeRandomized Controlled Trials as TopicStress, Psychological

Identifiers

PMID37715203
PMCPMC10504703
OpenAlexW4386772109

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.