Self-Management App for Patients With Left-Ventricular Assist Devices
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

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.
    

Detailed description: 
      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:
      self-efficacy and adherence to the LVAD home-care regimen; LVAD-related complications and
      healthcare utilizations; overall health status and QOL. A total of 40 patients (with
      caregivers) will be recruited. There will be 20 patients 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.
    

Intervention name(s): Mobile phone app (VAD Care App); Usual LVAD Care
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Heart-Assist Devices, Self-care, Quality of Life