Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3
Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3
The number of patients suffering from end-stage heart disease challenges healthcare services
 in the western world, where an estimated 1-2% of the population suffer from this chronic
 condition. Ventricular assist device (VAD) implantations have become a common therapeutic
 strategy for those affected. Live with a VAD, however, is far from normal and does expose
 patients to multiple challenges and the need to adjust to a complex self-management.
 Inadequate self-management can lead to serious complications, specifically neuro-cognitive
 events, bleeding, and exit-site related wound infections may impair the outcome following the
 VAD implantation procedure.

 Based on systematized literature review and a previous prevalence assessment study
 (ClinicalTrials.gov Identifier: NCT04234230), a modular evidence-based curriculum has been
 developed by a multiprofessional group of experts. This curriculum aims at improving
 knowledge, skills, and competencies for those affected to empower VAD patients to better
 self-manage their everyday life with the VAD, and to regain quality of life. This study
 focuses on a multi-center implementation and evaluation of the curriculum using a fully
 powered randomized-controlled study (RCT) design. This RCT will be conducted at four
 established cardiac centers throughout Germany. Participants will be assigned to either
 intervention or control using a 1: 1 randomization scheme. Block-randomization will be
 performed by a professional from the study coordinating center not being involved into the
 clinical care for patients. At the participating sites, the group assignment is non-blinded
 to the professionals involved in order to enable the intervention so be carried out
 adequately. Participants in the control group (CGr) receive the standard follow-up procedures
 (care as usual). Participants in the intervention group (IGr) receive self-management support
 and skills training based on the modular self-management curriculum post-implant, and during
 regular outpatient follow-up. The intervention lasts for 3 months followed by a 9-month
 follow-up per participant. Based on the power calculations the inclusion of 142 patients is
 anticipated.
The number of patients suffering from end-stage heart disease challenges healthcare services
 in the western world, where an estimated 1-2% of the population suffer from this chronic
 condition. Ventricular assist device (VAD) implantations have become a common therapeutic
 strategy for those affected. Indications include a multi-year bridging therapy (up to 10
 years) and increasingly a destination therapy. The Euromacs Registry published the second
 report in 2018 and reported 2,947 registered VAD implantations in 2016 (+257 percent).
 Euromacs further points to a rising trend and demand for the use of VAD systems for the
 treatment of patients with end-stage failure (NYHA classes III and IV). In Germany, an
 increase of VAD implantation by 36.6 percent has been reported since 2011. The position paper
 of the German Society of Cardiology (2016) warns that the range of indications for VAD
 implantation for people with chronic heart disease will continue to change. The ISHLT
 Guideline (International Society for Heart and Lung Transplantation), published in 2018,
 calls for psychosocial care and standardized self-management skills of patients before,
 during and in the long-term after VAD implantation. This is currently being implemented
 inconsistently in terms of structure and quality in German cardiac centers. Live with a VAD,
 however, is far from normal and does expose patients to multiple challenges and the need to
 adjust to a complex self-management. Inadequate self-management can lead to serious
 complications, specifically neuro-cognitive events, bleeding, and exit-site related wound
 infections may impair the outcome following the VAD implantation procedure.

 The design for this study will be a fully-powered block-randomized trial (RCT). This RCT will
 be conducted at four established cardiac centers throughout Germany. Participants will be
 assigned to either intervention or control using a 1: 1 randomization scheme.
 Block-randomization will be performed by a professional from the study coordinating center
 not being involved into the clinical care for patients. At the participating sites, the group
 assignment is non-blinded to the professionals involved in order to enable the intervention
 so be carried out adequately. Participants in the control group (CGr) receive the standard
 follow-up procedures (care as usual). Participants in the intervention group (IGr) receive
 self-management support and skills training based on the modular self-management curriculum
 post-implant, and during regular outpatient follow-up. The self-management training program
 will be supplemented by a smartphone-based application. The smartphone application will be
 downloaded optionally on the patients' own smartphones, and patients will be instructed on
 how to use it. In the app, the study participants can receive additional information on
 health-related data, e.g. weight, temperature, sleep or mood. Entering health related data is
 absolutely voluntary. No data will be transferred to the clinical sites. The study
 participants can also use the app to read VAD related information only without any
 registration. Data entered (optional) are used only for the participants' own information
 overview. The intervention lasts for 3 months followed by a 9-month follow-up period per
 participant. Based on the power calculations the inclusion of 142 patients is anticipated.

 The expected results can improve self-management, self-efficacy, and health-related quality
 of life for patients on VAD support. In addition, a reduction in VAD-specific complications
 and inpatient admission rates due to reduced complication rates can expected. The project
 aims to improve long-term psychosocial care through self-management support for patients on
 VAD support. The modular curriculum and the supporting
Inclusion Criteria:

 -  Stable postoperative condition

 -  Outpatient treatment at the respective heart center

 -  18 years and older

 -  No contraindications (e.g. Cognitive, Language)

 -  Signed Informed Consent

 Exclusion Criteria:

 -  Not an outpatient at the respective heart center

 -  Underage

 -  Contraindications (e.g. Cognitive, Language)

 -  No signed Informed Consent

 -  Participation in other behavior-related studies