A pilot clinical trial of a self-management intervention in patients with a left ventricular assist device

Jesus M. Casida, Marykay Pavol, Chakra Budhathoki, Heidi Craddock, Sarah E. Schroeder, Danyelle Hoff, Millie Tiburcio, Gregory Ewald

Research output: Contribution to journalArticlepeer-review

Abstract

Self-management is a health behavior known to predict treatment outcomes in patients with multiple co-morbidities and/or chronic conditions. However, the self-management process and outcomes in the left-ventricular assist device (LVAD) population are understudied. This pilot randomized control trial (RCT) evaluated the feasibility of a novel “smartphone app-directed and nurse-supported self-management intervention” in patients implanted with durable LVADs. Assessments included behavioral (self-efficacy and adherence), clinical (complications), and healthcare utilization (unplanned clinic, emergency room (ER) visits, and re-hospitalization) outcomes, completed at baseline (pre-hospital discharge) and months 1, 3, and 6 post-hospital discharge. Intervention patients (n = 14) had favorable patterns/trends of results across study outcomes than control patients (n = 16). Notably, intervention patients had much lower complications and healthcare utilization rates than controls. For example, intervention patients had 2 (14.3%) driveline infections in 6 months while control patients had 3 (19.0%). Additionally, at month 3, intervention patients had 0% ER visits versus 36% of control patients. At month 6, the mean cumulative number of re-hospitalizations for the control group was higher (0.9 ± 0.93) than intervention (0.3 ± 0.61) group. Despite the small sample size and limitations of feasibility/pilot studies, our outcomes data appeared to favor the novel intervention. Lessons learned from this study suggest the intervention should be implemented for 6 months post-hospital discharge. Further research is needed including large and rigorous multi-center RCTs to generate knowledge explaining the mechanism of the effect of self-management on LVAD treatment outcomes.

Original languageEnglish
Pages (from-to)91-104
Number of pages14
JournalJournal of Artificial Organs
Volume25
Issue number2
DOIs
StatePublished - Jun 2022

Keywords

  • LVAD self-management
  • Mechanical circulatory support
  • Nurse-supported self-management
  • Smartphone app intervention
  • Ventricular assist devices

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