N/A
N=40
Self-Management App for Patients With Left-Ventricular Assist Devices
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03049748 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Health-related Quality of Life — 49.8; 53.8; 72.7; 57.6 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile phone app (VAD Care App) (Device); Usual LVAD Care (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-related Quality of Life |
49.8; 53.8; 72.7; 57.6; 78.7; 75.4 | <0.05 sig |
| SECONDARY Self-efficacy |
85.0; 85.0; 89.9; 87.5; 95.2; 89.2 | >.05 |
| SECONDARY Health Status |
30.0; 31.2; 28.2; 28.5; 30.3; 28 | >.05 |
| SECONDARY Adherence |
89.9; 89.6; 89.8; 95.7; 95.5; 94.9 | >.05 |
| SECONDARY Complications |
68; 64.3; 47; 31; 38.5; 25 | >.05 |
| SECONDARY Hospital Readmission |
33.3; 7.1; 28.5; 0; 21.4; 8.3 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03049748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.