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.
Aims Ventricular assist device (VAD) implantation has become a well-established treatment strategy for patients suffering from advanced heart failure. Ventricular assist device treatment attempts to ameliorate the symptom burden but may create new challenges in patients’ lives. Lacking are insights into perceived challenges and health-related needs of patients with VAD within their home environment. Our study aimed to explore the perceived health-related needs of patients living with a VAD in their home environment. Methods and results We used a qualitative approach based on a hermeneutic, directed content analysis design. Telephone-based interviews were conducted with 10 patients with VAD from a single cardiology centre in Germany. Data collection and analyses were carried out using content-structuring content analyses. Normalcy and safety were identified as overarching themes: participants expressed a need to balance daily activities between striving for normalcy and maintaining safety. Underlying necessities reflecting this balance were categorized as functional, social, and mental health-related needs. Learning by doing, social-, and peer support were described as relevant requisites. Fulfilling these health-related needs could aid patients living with VAD in achieving the sense of normalcy and safety they seek. Conclusion Balancing health-related needs with striving for normalcy and safety, emerged as a new core concept for patients with VAD. Thus, being cognizant of this balance when caring for these patients, could facilitate coping after VAD implantation through increasing acceptance of limitations to daily functions by enhancing individual safety. A supportive social environment, including peer support, becomes vital in self-management programs preparing patients with VAD for their home environment.
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