Self-management (SM) for patients with a left ventricular assist device (LVAD) is complex, despite advancements in mechanical circulatory support. For patients and caregivers, managing an LVAD can be overwhelming. To address these challenges, a mobile phone application, the VAD Care App, has been developed to simplify and organize the LVAD SM process, potentially serving as a model for programs like the Alere Vad Care Program. This article explores the development and feasibility of this app as an SM tool, focusing on its acceptability, usability, and user competency with support from VAD coordinators.
The Critical Need for Enhanced LVAD Self-Management
LVAD self-management is a collaborative effort involving patients, caregivers, and VAD coordinators. This triadic approach acknowledges that modern SM extends beyond just the patient and caregiver managing treatment at home. Healthcare professionals are increasingly essential in helping patients with complex conditions achieve their self-management goals. In LVAD care, this involves patients and caregivers performing daily tasks and procedures supported by coordinators, aiming to maintain the LVAD system’s functionality and prevent complications, heart failure exacerbations, and hospital readmissions. Patients and caregivers gain the necessary skills through pre-discharge education and training, receiving resources like manuals and logs to track vital parameters.
However, challenges in LVAD self-management are well-documented, particularly in the initial months post-discharge. The sheer volume of information and complexity of the daily home-care regimen can be overwhelming, especially when coupled with the stress of adjusting to life with an LVAD. This can reduce self-efficacy and adherence to the daily routine, potentially leading to complications and readmissions. Therefore, innovative tools like mobile apps are crucial to simplify and enhance the LVAD self-management process, mirroring the goals of comprehensive programs such as the Alere VAD Care Program.
The VAD Care App: A Mobile Solution for LVAD Patients
To tackle the complexities of LVAD SM, the VAD Care app was developed as a mobile phone solution. This paper details the app’s development and assesses its feasibility as an LVAD SM tool, with a specific focus on evaluating user acceptability, usability, and competency.
Agile Development of the Mobile App
The Agile Model, a recognized software development methodology, guided the construction and testing of the VAD Care App prototype. This model includes conception, initiation and analysis, design and construction, and testing and deployment stages.
Conception: Focusing on the Self-Management Process
The app’s design and functionality prioritize key elements of the self-management process: self-efficacy, goal setting, self-monitoring/reporting, and coordinator support. Volunteer stakeholders, including patient-caregiver pairs and VAD coordinators, contributed to the app’s preliminary content, listing essential tasks and procedures. These were then organized based on common LVAD SM goals identified in clinical and research literature, ensuring real-world relevance and practicality. The prototype development began with an iOS operating system.
Table 1. Content of VAD Care App
| LVAD SM Goals and Behaviors |
|---|
| 1. Maintenance of LVAD System Functionality: Controller, Battery, Cables, Driveline self-testing |
| 2. Evaluation & Reporting of Abnormal Signs: LVAD parameters (speed, flow, power), Vital signs (BP, temp), Lab results (blood sugar, INR), Heart failure symptoms, Body weight |
| 3. Complication Prevention, Recognition & Reporting: Driveline care (sterile dressing changes, photo), Alarms, ICD firing, Urine/stool color, Bleeding |
| 4. Illness Burden Reduction & Overall Health Maintenance: Diet, Fluid intake, Medication & refills, Online LVAD education modules (lifestyle modifications, physical activity) |
Initiation and Analysis: Refining the App’s Design
Initial designs were deemed too complex and visually unappealing. Consultation with a technology solution architect and collaboration with a mobile health app development company led to a revised approach. A dedicated software development team, including engineers, designers, a solution architect, and an IT specialist, was assembled to plan subsequent development and testing phases.
Design and Construction: Key Features for Effective Self-Management
The app was designed with two primary goals: to simplify daily LVAD regimen management for patients and caregivers and to improve communication between patients, caregivers, and coordinators, mirroring the comprehensive support intended by programs like the Alere VAD Care Program. Key design features include:
- Automated Alerts: Daily push notifications remind patients to complete their regimen and submit a driveline exit site photo.
- Data Collection and Reporting: The app automatically identifies abnormal results and alerts coordinators in real-time via text messages.
- Dynamic Real-Time Interaction: A two-way communication system allows coordinators to assess and address abnormal results, conduct virtual clinic visits, perform home environment assessments, and review SM skills through videoconferencing. The app also includes readily accessible online LVAD SM videos.
Figures 1-5 illustrate app screens and summary reports, showcasing the app-directed SM process supported by VAD coordinators.
Figure 1.
Automated alerts (push notification) and launching screens
Figure 4.
Sample reports summary generated by the back-end server of VAD Care App 1.0
Figure 5.
Features of VAD Care App and App-Directed SM Process
Testing and Deployment: Ensuring User-Friendliness
The app’s content and question sequencing were refined by a multidisciplinary VAD care team. Beta-testing by five non-mobile app users provided objective feedback. Based on their input, fonts and buttons were enlarged, sliders were replaced with keypads for numerical data entry, and Wifi disconnection issues were resolved. The app was then copyrighted, and institutional review board approval was obtained before the feasibility study.
Feasibility Study: Evaluating Real-World Application
A mixed-method descriptive research design assessed the app’s feasibility in LVAD SM. Participants were recruited from two Midwest VAD Centers, meeting criteria including age (≥21 years), education (≥6th grade), English literacy, no cognitive impairment (MMSE score ≥24), and having an LVAD.
Study Procedures: Implementation and Training
The study began with user account creation, app download, and training by research staff. Proficiency was confirmed after at least two demonstrations of correct app usage. Participants were instructed to use the app daily for over 30 days. Technical support was provided throughout the study.
Data Collection: Measuring Acceptability, Usability, and Competency
Participant demographics and clinical data were collected through interviews and record reviews. Feasibility was assessed using a 15-item App Evaluation Questionnaire, covering acceptability, usability, and competency – key measures in mobile app feasibility studies. Acceptability (5 items) and usability (6 items) focused on ease of use and user experience. Competency (3 items) assessed user understanding of the app within LVAD SM. A 5-point Likert scale (1=strongly disagree to 5=strongly agree) was used. Higher scores indicated greater app acceptance, usability, and competency. Open-ended questions and semi-structured interviews provided qualitative data to clarify questionnaire responses and gather detailed user feedback.
Data Analysis: Quantitative and Qualitative Assessment
Descriptive statistics were used to analyze demographic and feasibility data. Content analysis was employed to analyze open-ended responses and interview transcripts. Two researchers independently coded and thematically analyzed the data to identify key themes related to user appraisals of the app.
Study Results: Positive User Feedback
From 11 patient-caregiver dyads screened, 9 participated, with 8 completing the 30-day study (8 patients and 8 caregivers). Most participants were White, married, and well-educated. Patients were on disability leave, while caregivers were primarily employed full-time. 63% of patients had axial flow LVADs, and 37% had centrifugal flow LVADs, with implant durations of 1-3 months. All participants had completed pre-discharge LVAD SM education and received standard post-discharge care.
Table 2. Participants’ Demographic Characteristics
| Characteristics | n (%)* |
|---|---|
| Patient (n=8) | |
| Gender | |
| Male | 8 (100) |
| Female | 0 |
| Race/Ethnicity | |
| Black | 1 (12.5) |
| White | 7 (87.5) |
| Marital Status | |
| Single/Divorced | 5 (62.5) |
| Married | 3 (37.5) |
| Education | |
| High School | 5 (62.5) |
| Some College | 2 (25.0) |
| College and beyond | 1 (12.5) |
| Employment | |
| Employed | 0 |
| Unemployed | 8 (100) |
*Due to rounding, not all percentages total 100
High Acceptability Scores and Feature Suggestions
Median acceptability scores ranged from 4.0 to 5.0, with caregivers scoring slightly higher than patients (4.9 vs. 4.4). Users suggested adding a “trending/tracking” function, such as a calendar to review past entries and track device averages, enhancing the app’s long-term value, similar to features potentially found in programs like the Alere VAD Care Program. Caregivers also requested medication reminder enhancements and adjustments to the driveline care question sequence. The “send a photo” function was particularly appreciated for its reassurance.
Table 3. Usability, Acceptability, and Competency of VAD Care App Users
| Domains and Items | Median and Interquartile Range (IQR) |
|---|---|
| Patients (n=8) | |
| Acceptability | |
| 1. Using the app helped me remember daily tasks (medications, LVAD care, etc.) | 5.0 (3.0–5.0) |
| 2. The app helped me organize my LVAD care tasks. | 4.0 (4.0–5.0) |
| 3. I’d prefer the app over a binder for LVAD records. | 5.0 (4.0–5.0) |
| 4. I’d use the app for LVAD care long-term. | 5.0 (4.0–5.0) |
| 5. Overall satisfaction with the app for LVAD care. | 4.0 (4.0–5.0) |
| Total Acceptability Score* | 4.4 (4.0–5.0) |
| Usability | |
| 1. The app is easy to use. | 5.0 (5.0) |
| 2. The app is reliable with few glitches. | 4.0 (3.0–4.0) |
| 3. The app is fast and responsive. | 5.0 (4.0–5.0) |
| 4. App button is easy to locate on my phone. | 5.0 (4.0–5.0) |
| 5. The phone display is easy to read. | 5.0 (4.0–5.0) |
| 6. The phone display is easy to understand. | 5.0 (5.0) |
| Total Usability Score* | 4.6 (4–4.8) |
| Competency | |
| 1. I understand the importance of completing app tasks for my LVAD and health. | 5.0 (4.0–5.0) |
| 2. I would recommend this app to other LVAD patients. | 5.0 (5.0) |
| 3. The app improved my connection with my LVAD team. | 4.0 (3.0–5.0) |
| Total Competency Score* | 4.3 (4.3–4.7) |
Note: Response scale: 1 = strongly disagree; 2 = disagree; 3 = neutral; 4 = agree; 5 = strongly agree;
*not statistically significant (p>.05)
Simplicity and Efficiency Drive High Usability
Median usability scores were also high, ranging from 4.0 to 5.0. Caregivers scored slightly lower than patients on usability (4.5 vs. 4.6). Simplicity and efficiency were key themes. Users found the app easy to use, even those less technologically inclined, and appreciated its efficiency in keeping them organized and providing helpful reminders. Online videos were a valuable resource, and patients preferred the app over traditional binders.
Competency in Communication and LVAD Management
Median competency scores ranged from 4.0 to 5.0, with caregivers scoring slightly higher (4.7 vs. 4.3). Users recognized the app as an efficient communication tool with coordinators, facilitating data sharing and timely team feedback, a crucial aspect of programs like the Alere VAD Care Program. They valued the direct communication with the VAD team and the benefit of daily data visibility for healthcare providers, contrasting it with the limitations of binder-based records.
Discussion: Mobile Apps as a Feasible LVAD Self-Management Tool
This study demonstrates the feasibility of using the VAD Care App as an LVAD SM tool in the home setting. This aligns with the growing trend of mobile phones supporting self-management for chronic conditions and is supported by healthcare stakeholders. Mobile phone ubiquity and provider preference for mobile communication further underscore the need for app-based solutions in healthcare, potentially mirroring comprehensive programs like the Alere VAD Care Program. Stakeholder input was central to the app’s design, grounded in theoretical, empirical, and clinical knowledge.
The VAD Care App stands out as a pioneering LVAD SM tool designed collaboratively by patients, caregivers, and coordinators. Its rigorous conceptualization and beta-testing differentiate it from other programs like VADWatch, LVAD@home, and VADable, which offer some overlapping features but lack a comprehensive SM process context. Notably, the VAD Care App incorporates automated alerts and a two-way communication system, features absent in other described programs, potentially enhancing treatment adherence and patient-provider interaction. These features can build self-efficacy by enabling task completion and providing constructive feedback, contributing to better self-management outcomes and quality of life. The high acceptability, usability, and competency ratings, along with high daily submission rates, suggest the app’s successful feasibility.
Figure 2.
LVAD SM goals, tasks completion, and submission screens
Figure 3.
Reporting, submission, and dynamic real-interaction feature
The study also sheds light on healthcare provider roles in app data management. VAD coordinators successfully integrated app data into their workflow, utilizing videoconferencing for remote assessments and finding data summaries helpful for patient care, demonstrating the practical application of such technologies in programs like the Alere VAD Care Program.
Limitations and Future Research Directions
Study limitations include a sample limited to iOS users, mobile phone-literate individuals with normal cognition, and Midwest residents. The sample size and questionnaire-based feasibility assessment are also acknowledged limitations. However, mixed-methods data collection helped offset these limitations, providing sufficient data for planning a pilot RCT and VAD Care App 2.0 development.
Future research should address these limitations with larger, diverse samples across multiple centers. Comprehensive evaluations of coordinator workload and longitudinal RCTs are needed to understand the app’s long-term effects on the LVAD SM process, outcomes, and sustainability. Further studies should also investigate the app’s mechanism of impact on behavioral, clinical, and health resource utilization outcomes, as well as adapt app functionality to evolving LVAD technology, ensuring programs like the Alere VAD Care Program remain at the forefront of patient care.
Conclusion: Towards Enhanced LVAD Care Programs
This study concludes that using a mobile app to assist LVAD patients and caregivers in managing complex care regimens is feasible. Longitudinal research is essential to further evaluate the VAD Care App’s long-term usability and acceptability and its impact on coordinator workload and patient/caregiver burden. Future research should focus on understanding how such apps improve self-efficacy, adherence, clinical outcomes, healthcare resource utilization, and quality of life. Ongoing revisions of app content and architecture are anticipated to align with advancements in LVAD technology, ultimately contributing to more effective and patient-centered LVAD care programs.
Acknowledgments
Source of Funding
This study was funded by NIH P20NR015331 and the University of Michigan School of Nursing.
The authors acknowledge Logic Solutions, Inc., Kinnothan Nelson, and the VAD care teams at the University of Michigan Health System and Barnes-Jewish Hospital Washington University for their contributions to the app’s development and testing.
Footnotes
Conflict of Interest
None
