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Self-Management App for Patients With Left-Ventricular Assist Devices

NCT03049748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-06-16

Study results available
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Summary

The purpose of this study is to evaluate the use of VAD Care App in an out-patient mechanical circulatory support program. The specific aim for this pilot study is to obtain preliminary efficacy data of the VAD Care App as a self-management tool for patients with long-term LVADs. A randomized control trial will be employed to establish preliminary estimates of the effects of the App on the following outcomes: self-efficacy and adherence to the LVAD care regimen; LVAD-related complications and health care utilization \[e.g., hospital re-admission\]; overall health status and quality of life. The duration of the study is 6 months.

Conditions

Interventions

DEVICE

Mobile phone app (VAD Care App)

VAD Care App is a novel self-management tool being tested for patients with implantable LVADs. The app has daily "push notifications (alerts)," cues for daily self-management tasks, two-way communication using text messages and videoconferencing (virtual clinic), and links to LVAD self-management skills and videos easily accessible for self-management skill review.

OTHER

Usual LVAD Care

Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge and as needed throughout the duration of the study.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Jesus Casida, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2019-05-30
Completion
2019-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049748 on ClinicalTrials.gov