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
2 other identifiers
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jan 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2017
CompletedFirst Submitted
Initial submission to the registry
February 4, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedResults Posted
Study results publicly available
May 27, 2020
CompletedJune 16, 2020
May 1, 2020
2.3 years
February 4, 2017
May 8, 2020
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Self-efficacy
Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Health Status
Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Adherence
1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Complications
1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Hospital Readmission
1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Study Arms (2)
Control Group
ACTIVE COMPARATORParticipants 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.
Intervention Group
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Washington University School of Medicinecollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (3)
Barnes-Jewish Hospital/Washington University
St Louis, Missouri, 63108, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
New York Presbyterian Columbia University Medical Center
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jesus Casida
- Organization
- Johns Hopkins University (Former Faculty at University of Michigan)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Casida, PhD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 4, 2017
First Posted
February 10, 2017
Study Start
January 30, 2017
Primary Completion
May 30, 2019
Study Completion
July 1, 2019
Last Updated
June 16, 2020
Results First Posted
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- September 2019 to 2021
- Access Criteria
- As described in the data sharing plan above
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.