A Preliminary Evaluation of Mobile Care App as Self-Management Tool in Patients With Left-Ventricular Assist Devices - Phase 2
Phase: NA
Conditions: Heart Failure
Sponsor: University of Michigan

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SELF-MANAGEMENT APP FOR PATIENTS WITH LEFT VENTRICULAR ASSIST 
DEVICES 
 
 
STUDY PROTOCOL & STATISTICAL ANALYSIS 
 
 
 
 
Jesus M. Casida, PhD  
 
University of Michigan  
Johns Hopkins University  
 
NCT # NCT03049748 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Purpose  
 
This study aimed to obtain preliminary efficacy data of using a mobile phone application 
(VAD Care App)1 as a self-management tool in patients with left-ventricular assist devices 
(LVAD). The specific aim was to evaluate the effects of the app on the patient's (1) self-
efficacy and (2) adherence to the LVAD care regimen; (3) complications; (4) overall health 
status, and (5) quality of life.  
 
Study Design 
 
Pilot randomized control trial. Measurements completed at baseline (T0) and months 1 
(1), 3 (T2), and 6 (T3) post-hospital discharge. 
 
Sample and Setting  
 
This study recruited a total of 68 patients with newly implanted, non-pulsatile flow durable 
LVADs and from four VAD Centers in the Midwest and Northeast regions in the United 
States. The study was implemented in inpatient and outpatient settings of the hospitals. 
 
Study Procedure 
 
Recruitment and screening.  A trained clinical research coordinator (CRC) conducted 
all recruitment and screening of study participants. Recruitment and obtaining informed 
consent occurred in each hospital’s inpatient setting. A screening checklist based on the 
study inclusion and exclusion criteria 
(table insert) was used. Since cognitive 
impairment is common in heart failure, 
we used the 11-item Mini-Mental State 
Exam (MMSE) as a screening tool. The 
MMSE is a valid, reliable, and widely 
used cognitive screening tool across 
care settings and conditions worldwide. 
A score of less than 24 in the MMSE 
denotes 
cognitive 
impairment.2,3 
Participation in this study also required 
a dedicated caregiver, a customary 
practice in the participating VAD 
centers.  
 
Randomization. 
Upon 
confirming 
eligibility to participate, patients were randomized in the study using a sample 
randomization procedure. Randomization, prepared by a statistician, using a computer-
generated 1:1 allocation of patients to either a control group or an intervention group. A 
coding scheme (ID#, site, study group), matching with the master list of patient names, 
as study participant identification was developed. Personally, identifiable data and group 

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assignments kept separately from other study data. Each site kept the study data in a 
locked cabinet and a password protected and encrypted desktop computer. 
 
• Control group: Patients received packets containing study instructions and self-
administered questionnaires. They also received the usual care throughout the 
study (6 months). Usual care is defined by the routine outpatient care customary 
to each VAD center. Many VAD Centers in the US share a similar approach to 
managing LVADs in outpatient clinics with routine follow-up care and as needed 
educational support (LVAD care) for patients/caregivers provided by specialized 
VAD nurses (RNs/NPs). Patients in the control group used the usual LVAD self-
management process consisting of the utilization of LVAD system operation 
manuals and videos and logs for daily care, self-monitoring, and reporting to any 
of the outpatient VAD RNs/NPs. It is also a common practice for VAD Centers to 
require patients and/or caregivers to bring their LVAD care logs during routine 
clinic visits. 
 
• Intervention group: Intervention patients performed LVAD self-management 
(assisted by caregivers as needed) as directed by the VAD Care App1 and 
supported by VAD RNs/NPs throughout the process. The app provided the patient 
with directions in completing the tasks and procedures required for daily LVAD 
care and management. It also provided an efficient channel of communication 
between RNs/NPs, patients and/or caregivers for interventions related to abnormal 
results (e.g., low LVAD flow), making recommendations to correct a deficit in 
knowledge and skills of LVAD self-management and to address other LVAD care-
related issues rapidly. Additionally, the app notified the RNs/NPs with text 
messages when a patient did not complete self-management for two consecutive 
days. In addition to receiving the usual care, patients in the intervention group had: 
 
a. Completed a study protocol training a day before discharge. First, the CRC 
downloaded the VAD Care App1 into an iOS or an Android-compatible 
smartphone owned by the participant or provided by the study team. 
Second, the CRC trained the patient and caregiver in the use of the app. 
Third, the CRC asked the patient and caregiver to demonstrate the use of 
the app at least twice to ensure proficiency in using the app.  
b. Received an intervention package consisting of study instructions, self-
administered questionnaires, and smartphones with the app ready for use 
at home. 
c. Used the app daily for a total of 6 months post-implantation hospital 
discharge. As prompted by the app, the patient and/or caregiver will 
implement the LVAD care regimen.  
d. Completed an “LVAD knowledge and skill review and evaluation" at week 
1, and months 1 and 5 to facilitate LVAD care self-efficacy and adherence. 
This review and evaluation were conducted by the VAD RNs/NPs during 
clinic visits or delivered via a video chat.   
 

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Data Collection. Data were collected at baseline (1-2 days before hospital discharge) 
and 1, 3, and 6 months after implantation hospitalization discharge. Approaches for data 
collection included reviews of a patient’s healthcare/medical record, completion of self-
administered questionnaires, and face-to-face interviews. The following data collection 
tools were used: 
 
• Demographic and Clinical Profiles. Common demographic data such as age, 
sex, race, education, and health history collected from informants (patients and/or 
caregivers). Clinical profiles included LVAD indication (implant strategy), model, 
and other pertinent clinical data, including comorbidities and risk stratification in 
advanced heart failure (INTERMACS Classifications).3 The Charlson Comorbidity 
Index (CCI), which evaluated 17 different comorbidities assigned to various 
weights (scores), were also employed. The CCI is a valid and reliable 
measurement instrument that is widely used for evaluating comorbidity indexes in 
cardiovascular, cardiac surgery, and LVAD patients.4,5 
 
• LVAD Care Self-Efficacy was measured with a 20-item LVAD Patient Self-
Efficacy Scale, used to assess a patient’s confidence in managing the challenges 
presented by the daily LVAD care regimen. The instrument employs a 6-point 
rating scale ranging from 0 (not confident at all) to 5 (extremely confident), with 
standardized sum scores ranging from 0 to 100.  High sum scores indicate higher 
confidence in one’s ability to manage the complexity of the regimen. The validity 
and reliability of the instrument were already established by factorial and 
convergent validity with a Cronbach’s alpha coefficient of 0.92.6-9 
 
• Adherence to the LVAD care regimen was measured with the 9-item LVAD Patient 
Home Management Adherence Scale, used to assess the degree of the patient’s 
consistency in completing the daily LVAD care. The instrument employs a 6-point 
rating scale, ranging from 0 (never) to 5 (all the time), with standardized sum 
scores ranging from 0 to 100. High sum scores indicate high adherence to the 
regimen. The validity and reliability of the instrument were also established by 
factorial and convergent validity with a Cronbach’s alpha coefficient of 0.95.6-9 
 
• Complications and Hospital Readmission. Two separate forms were created 
for capturing characteristics and frequency of LVAD-related complications and 
unplanned hospitalization through a monthly review of the patient’s medical 
record(s) and interviews of patients and/or caregivers. These forms consisted of a 
checklist and tables format, a commonly used approach for collecting 
complications and healthcare utilization/hospital readmission episodes in heart 
failure.10 
 
• Quality of Life was measured with the Kansas City Cardiomyopathy 
Questionnaire (KCCQ). This 23-item instrument used to assess several health-
related QOL domains, including physical function, symptoms, social function, 
among others. The instrument employs a 6-point Likert response scale with sum 

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scores ranging from 0 to 100. High sum scores indicate better quality of life. The 
validity, reliability, and sensitivity of the KCCQ have been well established in 
patients with heart failure and LVADs worldwide.11-13 
 
Data Analysis. All data management and statistical analyses performed with REDCap 
and SAS.14,15Study data were checked for quality and completeness. Data were also 
checked to ensure that assumptions were met before performing statistical analyses. 
Descriptive statistics and graphical displays used to summarize the data by the study 
group. Continuous variables summarized with medians and IQR or means and standard 
deviations, depending on the distribution. Categorical variables were summarized using 
percentages and frequencies. Differences in the study group's outcome variables were 
compared for each period (T0, T1, T2, and T3) with Mann Whitney U tests and chi-square 
tests set at 0.05 level of significance. Confidence intervals (95%) provided with the 
summary statistics as well as model estimates and effect size estimates for the next stage 
of this pilot. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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