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

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 analysisThis 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 disseminationEthical 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 numbersNCT04234230 and NCT04526964; Pre-results.

Validity and reliability of the self‐care behaviour scale for patients with left ventricular assist device

“…This can contribute to a more specific and clear presentation of LVAD self-care domains, including device management, wound management, symptom monitoring, activated healthcare system and selfcare management (Chmielinski & Koons, 2017;Kugler et al, 2021).…”

Mobile Health Intervention Contents and Their Effects on the Healthcare of Patients with Left Ventricular Assist Devices

“…The specific inclusion and exclusion criteria were as follows: Inclusion criteria: (1) studies published in all languages and (2) studies with no restrictions on the year of publication.…”

“…A s the number of patients with heart failure increases worldwide, the implantation of a left ventricular assist device (LVAD) is steadily increasing as a treatment option. 1,2 Patients with LVADs live a device-centered life as an artificial heart, powered by an external source, is inserted into their body. Furthermore, a driveline to the outside of the body is used to maintain it.…”

“…In addition, effort is required to lower readmission and mortality due to wound and complication management and emergency situations. 1,3 Left ventricular assist device implantation is seen as a process that goes beyond simply prolonging a patient's life, with the ultimate goal of improving quality of life. 2 Continuous monitoring and dynamic interaction with healthcare providers focusing on the device must be provided to effectively manage the patient's daily life.…”

“…Therefore, a balance between bleeding and infarction due to anticoagulation is required. In addition, effort is required to lower readmission and mortality due to wound and complication management and emergency situations 1,3 . Left ventricular assist device implantation is seen as a process that goes beyond simply prolonging a patient's life, with the ultimate goal of improving quality of life 2 .…”