Evidence map›Paper›PMID 33952544›Full record

ArticleBMJ open2021

Self-management for patients on ventricular assist device support: a national, multicentre study: protocol for a 3-phase study.

Christiane Kugler, Hannah Spielmann, Maiken Seemann, Volker Lauenroth, Renata Wacker, Wolfgang Albert, Christine Spitz-Koeberich, Sandra Semmig-Koenze, Maja von Cube, Katharina Tigges-Limmer

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 35% 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.

NCT04234230 completednot on this map

Improved Health Care for People With Chronic Heart Disease and Implanted Cardiac Support Through Curricular Self-management - Phase 1: Prevalence Study

TypeobservationalSponsorUniversity of FreiburgRan2019 to 2020Enrolled393ConditionsVentricular Assist Device, Self-management, Psychological FactorsArmsPrevalence Survey
NCT04526964 nacompletednot on this map

Improved Health Care for People With Chronic Heart Disease and Implanted Cardiac Support Through Curricular Self-management - Phase 3: Randomized Controlled Trial (RCT)

TypeinterventionalSponsorUniversity of FreiburgRan2020 to 2023Enrolled140ConditionsVentricular Assist Device, Psychosocial Factors, Self-managementArmsSelf-management curriculum
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
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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

10 authors at 5 institutions in 1 country.

Christiane KuglerInstitute of Nursing Science, University of Freiburg, Faculty of Medicine, Freiburg, Germany christiane.kugler@uniklinik-freiburg.de.ORCID 0000-0002-1422-2718
Hannah SpielmannInstitute of Nursing Science, University of Freiburg, Faculty of Medicine, Freiburg, Germany.
Maiken SeemannInstitute of Nursing Science, University of Freiburg, Faculty of Medicine, Freiburg, Germany.
Volker LauenrothMedical Psychology, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Nordrhein-Westfalen, Germany.
Renata WackerPsychosomatics, German Heart Center Berlin, Berlin, Germany.
Wolfgang AlbertPsychosomatics, German Heart Center Berlin, Berlin, Germany.
Christine Spitz-KoeberichUniversity Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.
Sandra Semmig-KoenzeUniversity Clinic for Heart Surgery, Heart Center Leipzig, Leipzig, Germany.
Maja von CubeInstitute of Medical Biometry and Statistics, University of Freiburg, Freiburg, Germany.
Katharina Tigges-LimmerMedical Psychology, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Nordrhein-Westfalen, Germany.
University of Freiburg · DEDeutsches Herzzentrum der Charité · DEHeart and Diabetes Center North Rhine-Westphalia · DELeipzig Heart Institute · DEUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSelf-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The 'SM model for patients on VAD support' will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum. METHODS AND ANALYSIS: This is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3. ETHICS AND DISSEMINATION: Ethical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English. TRIAL REGISTRATION NUMBERS: NCT04234230 and NCT04526964; Pre-results.

Indexed as

Heart-Assist DevicesSelf-ManagementChronic DiseaseEquivalence Trials as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as Topicheart failurerehabilitation medicinetransplant medicine

Identifiers

PMID33952544
PMCPMC8103388
OpenAlexW3157058166

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.