Evidence map›Paper›PMID 39625121›Full record

Trial reportArtificial organs2025

Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial.

Christiane Kugler, Hannah Spielmann, Fabian Richter, Volker Lauenroth, Sandra Semmig-Könze, Christine Spitz-Köberich, Tim Bertsche, Paulina Staus, Susanne Weber, Wolfgang Albert and 2 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Artificial organs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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

12 authors.

Christiane KuglerFaculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0002-1422-2718
Hannah SpielmannFaculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0001-8352-5424
Fabian RichterDepartment of Cardiothoracic and Vascular Surgery, German Heart Center Charité, Berlin, Germany.ORCID https://orcid.org/0000-0002-9655-4723
Volker LauenrothHeart and Diabetes Center North-Rhine Westphalia, University Hospital of the Ruhr University Bochum, Bad Oeynhausen, Germany.
Sandra Semmig-KönzeLeipzig Heart Center, University Clinic Heart Surgery, Leipzig, Germany.
Christine Spitz-KöberichMedical Center - University of Freiburg, University Heart Center Freiburg - Bad Krozingen, Freiburg, Germany.
Tim BertscheFaculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.
Paulina StausFaculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0003-0792-9229
Susanne WeberFaculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0002-4418-3836
Wolfgang AlbertDepartment of Cardiothoracic and Vascular Surgery, German Heart Center Charité, Berlin, Germany.
Katharina Tigges-LimmerHeart and Diabetes Center North-Rhine Westphalia, University Hospital of the Ruhr University Bochum, Bad Oeynhausen, Germany.ORCID https://orcid.org/0009-0001-5825-8405
Selma Study Group

Funding

The German Federal Joint Committee (G-BA)
6 · The paper itself

Abstract

backgroundUtilization of ventricular assist device (VAD) support in patients with end-stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence-based psychosocial support interventions for patients following VAD implantation.

methodsA national, multi-center study in four established German heart centers was initiated. An evidence-based VAD curriculum was developed; a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death); secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self-management [SELMA]). A total of 140 patients were randomized block-wise to intervention (IG n = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3).

resultsAt baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; p = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; p = 0.966); 80% were implanted electively (CG 79%; p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p > 0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18; 95% CI -2.17 to -0.18; p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%; CG 40.7%); increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >0.05) for QoL, social support, and self-management.

conclusionA comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.

Indexed as

DepressionHeart-Assist DevicesHeart FailureSelf-ManagementAgedAnxietyCurriculumFemaleGermanyHumansMaleMiddle AgedQuality of LifeSocial Supportcurriculumdepressionpsychosocial interventionself‐managementventricular assist device

Identifiers

PMID39625121
PMCPMC11848963

What OpenQuestion holds

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Registered trials

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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.