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

Abstract

Introduction: Self-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.

Keywords: heart failure; rehabilitation medicine; transplant medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Self-management model for patients on VAD support (modified after Schäfer-Keller et al29). INR, international normalised ratio; VAD, ventricular assist device.
Figure 2
Figure 2
Study design for the 3-phase study. App, Smartphone-based application; RCT, randomised controlled trial.
Figure 3
Figure 3
Study design for the randomised clinical trial in phase 3 of this study. INR, international normalised ratio; VAD, ventricular assist device.

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