Heart Failure
Conditions
Keywords
Heart-Assist Devices, Self-care, Quality of Life
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.
Interventions
DEVICEMobile 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.
OTHERUsual 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.
Sponsors
Washington University School of Medicine
National Institute of Nursing Research (NINR)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy | Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge. | 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). |
| Health Status | Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge. | 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). |
| Adherence | 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge. | 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) |
| Complications | 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge. | 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. |
| Hospital Readmission | 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge. | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 68 subjects were recruited and screened for study eligibility based on inclusion/exclusion criteria. Of these, 28 were excluded due to not meeting the study criteria (n=10) or refused to participate due to being overwhelmed with the newly implanted LVAD (n=15) and other reasons (n=3).
Participants by arm
| Arm | Count |
|---|---|
| Control Group Participants in the control group (20 LVAD patients) received usual care over 6 months. Usual care consisted routine clinic visits/follow-up at 1, 3, and 6 months post hospital discharge. A customary LVAD self-management/discharge education and training provided to patients and caregivers before hospital discharge and as need throughout the duration of the study. | 16 |
| Intervention Group Participants in the experimental group (20 LVAD patients) received usual care plus VAD Care App described in previous sections. They implemented LVAD self-management as directed by the app daily by patients and/or caregivers for over 6 months. Patient LVAD care self-management competencies were assessed at months 1 and 5 post hospital discharge with a review of LVAD care self-management skills provided by the LVAD RN Coordinator. | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Moved out of state (relocation) | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 12.9 | 52.3 years STANDARD_DEVIATION 14.4 | 52.07 years STANDARD_DEVIATION 13.04 |
| Health status | 30.0 units on a scale STANDARD_DEVIATION 8.3 | 31.2 units on a scale STANDARD_DEVIATION 5.4 | 31.0 units on a scale STANDARD_DEVIATION 6.8 |
| Quality of life | 83.2 units on a scale STANDARD_DEVIATION 20.11 | 86.0 units on a scale STANDARD_DEVIATION 27 | 85.0 units on a scale STANDARD_DEVIATION 23.4 |
| Race/Ethnicity, Customized Blacks | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Whites | 10 Participants | 12 Participants | 22 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Self-efficacy | 85.0 units on a scale STANDARD_DEVIATION 11 | 85.0 units on a scale STANDARD_DEVIATION 9.3 | 85.0 units on a scale STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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).
Time frame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Health-related Quality of Life | T0 | 49.8 score on a scale | Standard Deviation 18.7 |
| Control Group | Health-related Quality of Life | T1 | 72.7 score on a scale | Standard Deviation 17.3 |
| Control Group | Health-related Quality of Life | T2 | 78.7 score on a scale | Standard Deviation 14.6 |
| Control Group | Health-related Quality of Life | T3 | 83.3 score on a scale | Standard Deviation 18.7 |
| Intervention Group | Health-related Quality of Life | T3 | 74.7 score on a scale | Standard Deviation 23 |
| Intervention Group | Health-related Quality of Life | T0 | 53.8 score on a scale | Standard Deviation 26.2 |
| Intervention Group | Health-related Quality of Life | T2 | 75.4 score on a scale | Standard Deviation 19.8 |
| Intervention Group | Health-related Quality of Life | T1 | 57.6 score on a scale | Standard Deviation 22.6 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
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)
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Adherence | T2 | 89.8 score on a scale | Standard Deviation 8.7 |
| Control Group | Adherence | T3 | 95.5 score on a scale | Standard Deviation 6.6 |
| Control Group | Adherence | T1 | 89.9 score on a scale | Standard Deviation 10.7 |
| Intervention Group | Adherence | T1 | 89.6 score on a scale | Standard Deviation 15.9 |
| Intervention Group | Adherence | T2 | 95.7 score on a scale | Standard Deviation 6.6 |
| Intervention Group | Adherence | T3 | 94.9 score on a scale | Standard Deviation 5.9 |
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Complications | T1 | 68 percentage of number of complications |
| Control Group | Complications | T2 | 47 percentage of number of complications |
| Control Group | Complications | T3 | 38.5 percentage of number of complications |
| Intervention Group | Complications | T1 | 64.3 percentage of number of complications |
| Intervention Group | Complications | T2 | 31 percentage of number of complications |
| Intervention Group | Complications | T3 | 25 percentage of number of complications |
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
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).
Time frame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Health Status | T3 | 30.1 score on a scale | Standard Deviation 3.6 |
| Control Group | Health Status | T1 | 28.2 score on a scale | Standard Deviation 5.1 |
| Control Group | Health Status | T0 | 30.0 score on a scale | Standard Deviation 8.3 |
| Control Group | Health Status | T2 | 30.3 score on a scale | Standard Deviation 2.9 |
| Intervention Group | Health Status | T0 | 31.2 score on a scale | Standard Deviation 5.4 |
| Intervention Group | Health Status | T2 | 28 score on a scale | Standard Deviation 28.5 |
| Intervention Group | Health Status | T3 | 29 score on a scale | Standard Deviation 4.7 |
| Intervention Group | Health Status | T1 | 28.5 score on a scale | Standard Deviation 2.9 |
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Hospital Readmission | T1 | 33.3 percentage of re-hospitalizations |
| Control Group | Hospital Readmission | T2 | 28.5 percentage of re-hospitalizations |
| Control Group | Hospital Readmission | T3 | 21.4 percentage of re-hospitalizations |
| Intervention Group | Hospital Readmission | T1 | 7.1 percentage of re-hospitalizations |
| Intervention Group | Hospital Readmission | T2 | 0 percentage of re-hospitalizations |
| Intervention Group | Hospital Readmission | T3 | 8.3 percentage of re-hospitalizations |
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
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).
Time frame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Self-efficacy | T0 | 85.0 score on a scale | Standard Deviation 10.9 |
| Control Group | Self-efficacy | T1 | 89.9 score on a scale | Standard Deviation 7.4 |
| Control Group | Self-efficacy | T2 | 95.2 score on a scale | Standard Deviation 7.7 |
| Control Group | Self-efficacy | T3 | 96.9 score on a scale | Standard Deviation 7.4 |
| Intervention Group | Self-efficacy | T3 | 94.5 score on a scale | Standard Deviation 10.3 |
| Intervention Group | Self-efficacy | T0 | 85.0 score on a scale | Standard Deviation 9.3 |
| Intervention Group | Self-efficacy | T2 | 89.2 score on a scale | Standard Deviation 16.7 |
| Intervention Group | Self-efficacy | T1 | 87.5 score on a scale | Standard Deviation 11.5 |
p-value: >0.05Wilcoxon (Mann-Whitney)