Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Article
  • Artificial Heart (Clinical)
  • Published:
Journal of Artificial Organs Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

© architecture and patient/caregiver-nurse dynamic interactions

Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Casida JM, Aikens J, Pagani F, et al. Advancing the science of self-management in adults with long-term left ventricular assist devices. Artif Organs. 2018;42:1095–103.

    Article  Google Scholar 

  2. Casida JM, Wu HS, Abshire M, Ghosh B, Yang JJ. Cognition and adherence are self-management factors predicting the quality of life of adults living with a left ventricular assist device. J Heart Lung Transpl. 2017;36:325–30.

    Article  Google Scholar 

  3. Casida JM, Wu H, Senkiv V, Yang J. Self-efficacy and adherence are predictors of quality of life in patients with left ventricular assist devices. J Heart Lung Transpl. 2016;35:S90-91.

    Article  Google Scholar 

  4. Casida JM, Combs P, Pavol M, Hickey KT. Ready, set, go: How patients and caregivers are prepared for self-management on an implantable ventricular assist device. ASAIO J. 2018;64:e151–5.

    Article  Google Scholar 

  5. Marcuccilli L, Casida JM. From insiders’ perspectives: adjusting to care giving for patients with LVADs. Prog Transpl. 2011;21:137–43.

    Article  Google Scholar 

  6. Casida JM, Combs P, Schoreder SE, Hickey KT. Ventricular assist device self-management issues: the patient and caregiver perspectives. ASAIO J. 2018;64:e148–50.

    Article  Google Scholar 

  7. Casida JM, Wu H. Association among care dependency, cognition, and self-efficacy in patients with left ventricular assist devices. J Heart Lung Transpl. 2016;35:S145-146.

    Article  Google Scholar 

  8. Patel S, Poojary P, Pawar S, et al. National landscape of unplanned 30-day readmissions in patients with left ventricular assist device implantation. Am J Cardiol. 2018;122:261–7.

    Article  Google Scholar 

  9. Vidula H, Kutyifa V, Johnson BA, et al. Readmission patterns during long-term follow-up after ventricular assist device implantation. Am J Cardiol. 2018;122:1021–7.

    Article  Google Scholar 

  10. Casida JM, Aikens JE, Craddock H, Aldrich MW, Pagani FD. Development and feasibility of self-management application in left-ventricular assist devices. ASAIO J. 2018;64:159–67.

    Article  Google Scholar 

  11. Casida JM, Pavol M, Craddock H, Schroeder SE, Cagliostro B, Budhathoki C. Patient-reported issues following left ventricular assist device implantation hospitalization. ASAIO J. 2021;67:658–65.

    Article  Google Scholar 

  12. Reisberg B, Ferris SH, Leon MJ, et al. The global deterioration scale for assessment of primary degenerative dementia. A J Psychiatry. 1982;139:1136–9.

    Article  CAS  Google Scholar 

  13. IBM Corp. SPSS software version 25.0. Armonk, NY: Author; 2018.

  14. Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why, and how. BMC Med Res Method. 2010;10:1–10.

    Article  Google Scholar 

  15. National Institutes of Health Center for Complementary and Integrative Health. Pilot studies: Common uses and Misuses. Accessed 1 May 2021. https://www.nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses

  16. Buck HG, Akbar JA, Zhang SJ, Bettger JA. Measuring comorbidity in cardiovascular research: a systematic review. Nurs Res Pract. 2013. https://doi.org/10.1155/2013/563246.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Casida JM. Using mobile phone app to empower care and self-management in LVAD patients. Heart Asia. 2019;11:A3.

    Google Scholar 

  18. Casida JM, Wu HS, Harden J, Chern J, Carie A. Development and initial evaluation of the psychometric properties of self-efficacy and adherence scales for patients with a left ventricular assist device. Prog Transpl. 2015;25:107–15.

    Article  Google Scholar 

  19. SAS Institute Inc. SAS/STAT 13.2 User’s Guide. Cary, NC: Author; 2015.

  20. Hohmann S, Veltmann C, Duncker D, et al. Initial experience with telemonitoring in left ventricular assist device patients. J Thorac Dis. 2019;11:S853–63.

    Article  Google Scholar 

  21. Kimmi Ko KH, Dunn JL, Straker K, Nusem E, Wrigley C, Gregory S. A comparative content analysis of digital channels for ventricular assist device patients, caregivers, and healthcare practitioners. ASAIO. 2019;65:855–63.

    Article  Google Scholar 

  22. Schmidt T, Mewes P, Hoffman JD, Muller-von Aschwege F, Glitza J, Schmitto J, Schulte-Eistrup S. Improved aftercare in LVAD patients: development and feasibility of a smartphone application as a first step for telemonitoring. Artif Organs. 2020;44:248–56.

    Article  Google Scholar 

  23. Voils CI, Chang Y, Candell J, Leeman J, Sandelowski M, Maciejewski ML. Informing the dosing of interventions in randomized trials. Contemp Clin Trials. 2012;33:1225–30.

    Article  Google Scholar 

  24. Resnick B, Galik E, Pretzer-Aboff I, Gruber-Baldini AL, Russ K, Cayo J, Zimmerman S. Treatment fidelity in nursing home research: the Res-Care Intervention Study. Res Gerontol Nurs. 2009;2:30–8.

    Article  Google Scholar 

  25. Baumgartner PC, Haynes RB, Hersberger KE, Arnet I. A systematic review of medication adherence thresholds dependent of clinical outcomes. Front Pharmacol. 2018;9:1290.

    Article  Google Scholar 

  26. Giner-Soriano M, Sotorra Figuerola G, Cortés J, Pera Pujadas H, Garcia-Sangenis A, Morros R. Impact of medication adherence on mortality and cardiovascular morbidity: protocol for a population-based cohort study. JMIR Res Protoc. 2018;7:73.

    Article  Google Scholar 

  27. Stevenson LW, Pagani FD, Young JB. INTERMACS profile of advanced heart failure: the current picture. Heart Lung Transpl. 2009;28:534–41.

    Article  Google Scholar 

  28. Waltz CF, Strickland OL, Lenz ER. Measurement in nursing and health research. 4th ed. New York: Springer; 2010.

    Google Scholar 

Download references

Acknowledgements

This study was funded by the NIH National Institute of Nursing Research (P20NR015331) and the D. K. Allen Foundation administered by the University of Michigan School of Nursing, Ann Arbor, MI. We also would like to acknowledge the contributions of VAD RNs and NPs in completing this study in the following VAD Centers in the United States: Barnes-Jewish Hospital, St. Louis, MO, University of Michigan, Ann Arbor, MI, Columbia University, New York, NY, and Bryant Heart, Lincoln, NE.

Author information

Authors and Affiliations

  1. Johns Hopkins University School of Nursing, Baltimore, MD, USA

    Jesus M. Casida & Chakra Budhathoki

  2. New York-Presbyterian Columbia University Medical Center, New York, NY, USA

    Marykay Pavol & Millie Tiburcio

  3. Barnes-Jewish Hospital Washington University, St. Louis, MO, USA

    Heidi Craddock, Danyelle Hoff & Gregory Ewald

  4. Bryant Heart, Lincoln, NE, USA

    Sarah E. Schroeder

Authors
  1. Jesus M. Casida
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marykay Pavol
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Chakra Budhathoki
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Heidi Craddock
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sarah E. Schroeder
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Danyelle Hoff
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Millie Tiburcio
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Gregory Ewald
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Jesus M. Casida or Marykay Pavol.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Casida, J.M., Pavol, M., Budhathoki, C. et al. A pilot clinical trial of a self-management intervention in patients with a left ventricular assist device. J Artif Organs 25, 91–104 (2022). https://doi.org/10.1007/s10047-021-01289-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10047-021-01289-x

Keywords

Search

Navigation