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

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

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Usual LVAD Care; Device: Mobile phone app (VAD Care App)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Barnes-Jewish Hospital/Washington University
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants in the control group (20 LVAD patients) will receive usual care over 6 months. Usual care consists of routine clinic visits/follow-up at 1, 3, and 6 months post hospital discharge. A customary LVAD self-management/discharge education and training will be provided to patients and caregiver before hospital discharge and as need throughout the duration of the study. The control group will NOT receive the VAD Care App.	Other: Usual LVAD Care; 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.
Experimental: Intervention Group; Participants in the experimental group (20 LVAD patients) will receive usual care plus VAD Care App. They will implement LVAD self-management as directed by VAD Care App. The app will be used daily by patients and/or caregivers for over 6 months. Their LVAD self-management competencies will be assessed at months 1 and 5 post hospital discharge with a review of LVAD self-management skills provided by the LVAD RN Coordinator.	Other: Usual LVAD Care; 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.; Device: Mobile phone app (VAD Care App); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life	Measured with the Kansas City Cardiomyopathy Questionnaire. A self-administered instrument consisting 23 items yielding a minimum and maximum values of 0 to 100 (overall summary score). Higher scores mean a better quality of life (i.e., a better outcome).	Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	Measured with the LVAD Patient Self-Efficacy Scale. A self-administered instrument consisting 20 items with possible minimum and maximum values of 0 to 100 (standardized score). Higher scores mean a better self-efficacy (confidence) for managing daily LVAD care regimen (i.e., better outcome).	Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Health Status	Measured with PROMIS Global Health Short Form v1. This self-administered instrument consisted of 10 items with possible minimum and maximum values of 10 to 50 (sum scores). Higher sum scores mean a better health status (i.e., better outcome).	Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Adherence	Measured with LVAD Patient Home Management Adherence Scale. This self-administered instrument consisted 9 items with possible minimum and maximum values of 0 to 100 (standardized score). Higher sum scores mean a better adherence to daily LVAD care (i.e., a better outcome)	1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Complications	Number/frequency of complications were collected and recorded on an LVAD-related Complications Tracking Form. Data collections took place from day 0 to months 6 post hospital discharge. Minimum and maximum values were 0 to any possible values. Higher number of complications mean a worse outcome.	1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Hospital Readmission	Number/frequency of unplanned hospitalizations were recorded on LVAD Hospital Readmission Form. All-cause of unplanned hospitalization/readmission were collected from day 0 to 6 months post hospital discharge.	1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Washington University School of Medicine; National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Jesus Casida, PhD, University of Michigan

Publications and helpful links

Helpful Links

• Project Information Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 4, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Heart-Assist Devices, Self-care, Quality of Life
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HUM00092092; 1P20NR015331-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing will be made available for research to those who request it once analyses of specific aims have been conducted and findings have been published. All data will be de-identified. Persons interested in using the data will need to submit a request in writing, stating their intended use. Data will be made available at cost. Requirements for sharing will include acknowledgement in all publications of the funding source and of the study authors. Data sets will be accompanied by a data dictionary for all study variables, both derived and raw data. We will consider the most cost-effective means for sharing data after a data-sharing agreement has been reached. For example, data may be copied to a CD or DVD, be posted on a password protected and secure web site, or made available through a third party data archive service. We will also share research findings through publications and presentations at scholarly research meetings.
• IPD Sharing Time Frame: September 2019 to 2021
• IPD Sharing Access Criteria: As described in the data sharing plan above
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No