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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2019-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual LVAD Care

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Mobile phone app (VAD Care App)

Intervention Type DEVICE

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.

Usual LVAD Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No