Clinical trial NCT03049748: Self-Management App for Patients With Left-Ventricular Assist Devices
Official title: A Preliminary Evaluation of Mobile Care App as Self-Management Tool in Patients With Left-Ventricular Assist Devices - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart-Assist Devices, Self-care, Quality of Life
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: National Institute of Nursing Research (NINR)
First posted: 2017-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Secondary outcomes:
measure: Self-efficacy
timeFrame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
measure: Health Status
timeFrame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
measure: Adherence
timeFrame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
measure: Complications
timeFrame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
measure: Hospital Readmission
timeFrame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital/Washington University
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: New York
country: United States
facility: New York Presbyterian Columbia University Medical Center
state: New York
Study officials:
affiliation: University of Michigan
name: Jesus Casida, PhD
role: PRINCIPAL_INVESTIGATOR
References: