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

About 250,000 of 5.8 million Americans are suffering from an advanced or end-stage heart
failure. Generally, these individuals require a heart transplant or a mechanical circulatory
support such as a left-ventricular assist device (LVAD). LVAD is implanted to liberate
patients from crippling symptoms of heart failure, or in some cases avert imminent death.
However, maintaining health and improving quality of life (QOL) depend on a "trouble-free"
LVAD. Despite the refinement in circulatory support technology, many patients and their
family caregivers still face challenges in managing the LVAD in home settings. The LVAD
home-care regimen comprise of complex technical and non-technical tasks and procedures that
must be implemented frequently and consistently. During the first 6 months following hospital
discharge, patients/caregivers generally exhibit low levels of confidence (i.e.,
self-efficacy) in managing the tasks/procedures. This problem appears to contribute to low
adherence to the regimen and poor outcomes. The current self-management processes include
provision of instructional manuals and logs for vital signs, LVAD parameters, etc. To address
this problem, the research team developed a mobile phone VAD Care App as a self-management
tool. The app will aid and may ease patients/caregivers' problems in managing the complexity
of the home-care regimen. The app offers patients/caregivers with (a) daily reminders about
the tasks/procedures to be performed, (b) videoconferencing feature to communicate with
healthcare providers about LVAD and health issues, and (c) on-line LVAD training/education.
The prototype of the app was tested by 16 patients and caregivers. Results included ease of
use and high acceptability and competency rates among users.The specific aim for the present
study is to obtain preliminary efficacy data of the care app as self-management tool in
patients with a long-term LVAD. This study will employ a randomized control trial to
establish preliminary estimates of the effects of the care app on the following: (1) the
patients and caregivers' self-efficacy and (2) adherence to the LVAD home-care regimen; (3)
LVAD-related complications and healthcare utilizations; and (4) patients' overall health
status and (5) QOL. A total of 40 patient-caregiver dyads will be recruited. There will be 20
patients/caregivers allocated in the control (usual care) and experimental (usual care + VAD
Care App) groups. Data collection will be performed during pre-hospital discharge (baseline)
and at 1, 3 and 6 months post discharge using self-administered questionnaires, chart
reviews, interviews, and retrieval of historical data of the care app. Descriptive and
inferential statistical procedures will be employed for data analysis. The outcome of this
pilot will inform the next stages of investigations that are crucial for transforming LVAD
self-management processes and improving outcomes.

Inclusion Criteria:

- Patients: Recipient of second or third generation LVAD; minimum of 6th grade
education; can read and understand the English Language; and to be discharged from the
hospital within a week of enrollment

- Caregivers: Designated as primary caregiver at home and a minimum of 6th grade
education

Exclusion Criteria:

- Patients and caregivers: Illiterate, blind, inability to use a mobile phone, cannot
hear alarms, and/or evidence of cognitive impairment documented in the medical record
or an abnormal results of a Mini Mental State Exam