CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 143 enrolled
Drug / intervention
Simulation-based Mastery Learning (SBML)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03073005
NCT03073005N/ACompleted

Use of Simulation to Improve Ventricular Assist Device Self-management

Northwestern University·interventional·Posted Mar 8, 2017·Updated May 10, 2021

In Brief

A clinical study evaluating Simulation-based Mastery Learning (SBML) for Heart Failure. Completed, enrolled 143 participants across 1 site.

Detailed Summary

This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted into the heart to help circulate the blood). The investigators expect this training will improve self-management skills, and reduce VAD-related infections and re-hospitalizations. In addition to providing innovative training to the patients and their caregivers, the study will advance our knowledge of the effects of simulation-based training on patient self-management and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 8, 2017
Enrollment StartJun 1, 2017
Primary CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.3 years ago

Interventions

Simulation-based Mastery Learning (SBML)other

The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.