CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Mobile phone app (VAD Care App) +1 moredevice
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/NCT03049748
NCT03049748N/ACompleted

A Preliminary Evaluation of Mobile Care App as Self-Management Tool in Patients With Left-Ventricular Assist Devices - Phase 2

University of Michigan·interventional·Posted Feb 10, 2017·Updated Jun 16, 2020

In Brief

A clinical study evaluating Mobile phone app (VAD Care App) and Usual LVAD Care for Heart Failure. Completed, enrolled 40 participants across 3 sites.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 10, 2017
Enrollment StartJan 30, 2017
Primary CompletionMay 30, 2019
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.4 years ago

Interventions

Mobile phone app (VAD Care App)device

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.

Usual LVAD Careother

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.