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.
Subject(s)
Heart-Assist Devices , Self-Management , Chronic Disease , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Ventricular assist device (VAD) implantation has become an established treatment strategy for the increasing number of patients with advanced heart failure. Adequate patient self-management becomes essential to prevent adverse events, which could diminish expected outcomes and survival for patients on VAD support. OBJECTIVES: The aim of this study was to provide an overview of the current state of evidence concerning self-management in VAD patients through a systematized search and mapping of the literature. METHODS: Following the scoping review process, a comprehensive literature search (PubMed, PsychInfo), tabular synthesis of included articles, and data analysis of synthesized findings were performed. RESULTS: Overall, twenty articles were included. Results describe the complexity of regular self-management tasks and give direction for specific self-management training. CONCLUSIONS: This article represents the first comprehensive overview of available evidence suggesting the need for development and implementation of evidence-based, patient self-management curricula with therapeutic regimen for VAD patients.
