Trial Outcomes & Findings for Self-Management App for Patients With Left-Ventricular Assist Devices (NCT NCT03049748)
NCT ID: NCT03049748
Last Updated: 2020-06-16
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Results posted on
2020-06-16
Participant Flow
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).
Participant milestones
| Measure |
Control Group
Participants in the control group (20 LVAD patients and 20 caregivers) 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.
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 Group
Participants in the experimental group (20 LVAD patients and 20 caregivers) 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.
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.
Usual LVAD Care: Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Control Group
Participants in the control group (20 LVAD patients and 20 caregivers) 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.
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 Group
Participants in the experimental group (20 LVAD patients and 20 caregivers) 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.
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.
Usual LVAD Care: Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Moved out of state (relocation)
|
0
|
1
|
Baseline Characteristics
Self-Management App for Patients With Left-Ventricular Assist Devices
Baseline characteristics by cohort
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
52.07 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Blacks
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Whites
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Self-efficacy
|
85.0 units on a scale
STANDARD_DEVIATION 11.0 • n=5 Participants
|
85.0 units on a scale
STANDARD_DEVIATION 9.3 • n=7 Participants
|
85.0 units on a scale
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Health status
|
30.0 units on a scale
STANDARD_DEVIATION 8.30 • n=5 Participants
|
31.2 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
31.0 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Quality of life
|
83.2 units on a scale
STANDARD_DEVIATION 20.11 • n=5 Participants
|
86.0 units on a scale
STANDARD_DEVIATION 27.0 • n=7 Participants
|
85.0 units on a scale
STANDARD_DEVIATION 23.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
|---|---|---|
|
Health-related Quality of Life
T0
|
49.8 score on a scale
Standard Deviation 18.7
|
53.8 score on a scale
Standard Deviation 26.2
|
|
Health-related Quality of Life
T1
|
72.7 score on a scale
Standard Deviation 17.3
|
57.6 score on a scale
Standard Deviation 22.6
|
|
Health-related Quality of Life
T2
|
78.7 score on a scale
Standard Deviation 14.6
|
75.4 score on a scale
Standard Deviation 19.8
|
|
Health-related Quality of Life
T3
|
83.3 score on a scale
Standard Deviation 18.7
|
74.7 score on a scale
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
|---|---|---|
|
Self-efficacy
T0
|
85.0 score on a scale
Standard Deviation 10.9
|
85.0 score on a scale
Standard Deviation 9.3
|
|
Self-efficacy
T1
|
89.9 score on a scale
Standard Deviation 7.4
|
87.5 score on a scale
Standard Deviation 11.5
|
|
Self-efficacy
T2
|
95.2 score on a scale
Standard Deviation 7.7
|
89.2 score on a scale
Standard Deviation 16.7
|
|
Self-efficacy
T3
|
96.9 score on a scale
Standard Deviation 7.4
|
94.5 score on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
|---|---|---|
|
Health Status
T0
|
30.0 score on a scale
Standard Deviation 8.3
|
31.2 score on a scale
Standard Deviation 5.4
|
|
Health Status
T1
|
28.2 score on a scale
Standard Deviation 5.1
|
28.5 score on a scale
Standard Deviation 2.9
|
|
Health Status
T2
|
30.3 score on a scale
Standard Deviation 2.9
|
28 score on a scale
Standard Deviation 28.5
|
|
Health Status
T3
|
30.1 score on a scale
Standard Deviation 3.6
|
29 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
|---|---|---|
|
Adherence
T1
|
89.9 score on a scale
Standard Deviation 10.7
|
89.6 score on a scale
Standard Deviation 15.9
|
|
Adherence
T2
|
89.8 score on a scale
Standard Deviation 8.7
|
95.7 score on a scale
Standard Deviation 6.6
|
|
Adherence
T3
|
95.5 score on a scale
Standard Deviation 6.6
|
94.9 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
|---|---|---|
|
Complications
T1
|
68 percentage of number of complications
|
64.3 percentage of number of complications
|
|
Complications
T2
|
47 percentage of number of complications
|
31 percentage of number of complications
|
|
Complications
T3
|
38.5 percentage of number of complications
|
25 percentage of number of complications
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=16 Participants
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.
|
Intervention Group
n=14 Participants
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.
|
|---|---|---|
|
Hospital Readmission
T1
|
33.3 percentage of re-hospitalizations
|
7.1 percentage of re-hospitalizations
|
|
Hospital Readmission
T2
|
28.5 percentage of re-hospitalizations
|
0 percentage of re-hospitalizations
|
|
Hospital Readmission
T3
|
21.4 percentage of re-hospitalizations
|
8.3 percentage of re-hospitalizations
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jesus Casida
Johns Hopkins University (Former Faculty at University of Michigan)
Phone: 3132047665
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place