Evidence map›Paper›PMID 34342807›Full record

Trial reportJournal of artificial organs : the official journal of the Japanese Society for Artificial Organs2022

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

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jesus M CasidaJohns Hopkins University School of Nursing, Baltimore, MD, USA. jcasida1@jhu.edu.ORCID http://orcid.org/0000-0001-6342-8504
Marykay PavolNew York-Presbyterian Columbia University Medical Center, New York, NY, USA. MP2740@cumc.columbia.edu.
Chakra BudhathokiJohns Hopkins University School of Nursing, Baltimore, MD, USA.
Heidi CraddockBarnes-Jewish Hospital Washington University, St. Louis, MO, USA.
Sarah E SchroederBryant Heart, Lincoln, NE, USA.
Danyelle HoffBarnes-Jewish Hospital Washington University, St. Louis, MO, USA.
Millie TiburcioNew York-Presbyterian Columbia University Medical Center, New York, NY, USA.
Gregory EwaldBarnes-Jewish Hospital Washington University, St. Louis, MO, USA.

Funding

Pilot Projects CoreP20NR015331 · NINR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LARSON, JANET L. · 2014 to 2018
$1.3M
NINR NIH HHS P20NR015331
6 · The paper itself

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.

Indexed as

Heart-Assist DevicesHeart FailureSelf-ManagementHospitalizationHumansTreatment OutcomeLVAD self-managementMechanical circulatory supportNurse-supported self-managementSmartphone app interventionVentricular assist devices

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.