Heart FailureNCT03049748
Self-Management App for Patients With Left-Ventricular Assist Devices
A study testing Mobile phone app (VAD Care App) and Usual LVAD Care in people with Heart Failure, run by University of Michigan at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Mobile phone app (VAD Care App) and Usual LVAD Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bryan Heart
Lincoln, Nebraska, 68506
New York Presbyterian Columbia University Medical Center
New York, New York, 10032
Barnes-Jewish Hospital/Washington University
St Louis, Missouri, 63108
About this study
Official title: A Preliminary Evaluation of Mobile Care App as Self-Management Tool in Patients With Left-Ventricular Assist Devices - Phase 2
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Mobile phone app (VAD Care App), Usual LVAD Care
- Keywords
- Heart-Assist Devices, Self-care, Quality of Life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone app (VAD Care App)Device
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants 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. Receives: Other: Usual LVAD Care |
| Intervention Group | Experimental | Participants 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. Receives: Device: Mobile phone app (VAD Care App); Other: Usual LVAD Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Secondary outcomes (5)
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).
Measured: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
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).
Measured: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
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)
Measured: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
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.
Measured: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
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.
Measured: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start30 Jan 2017
- Primary completion30 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jesus Casida, University of Michigan
- Investigators
- Jesus Casida, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049748
- Sponsor's protocol ID
- HUM00092092
- Other IDs
- 1P20NR015331-01
- Status last verified
- May 2020
- First submitted
- 4 Feb 2017
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Evaluation of Mobile Care App as Self-Management Tool in Patients With Left-Ventricular Assist Devices - Phase 2
- ClinicalTrials.gov ID
- NCT03049748
- Acronym / sponsor ID
- HUM00092092
- Conditions
- Heart Failure
- Keywords
- Heart-Assist Devices, Self-care, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, National Institute of Nursing Research (NINR)
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Usual LVAD CareParticipants 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 | Experimental | Device: Mobile phone app (VAD Care App), Other: Usual LVAD CareParticipants 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention Group |
| Usual LVAD CareRoutine 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. | Other | Control Group, Intervention Group |
Primary outcome
Health-related Quality of Life
Time frame: 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).
5 secondary outcomes
Self-efficacy
Time frame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Health Status
Time frame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.
Adherence
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Complications
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Hospital Readmission
Time frame: 1 month (T1), 3 months (T2), and 6 months (T3) post hosp discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Project Information SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Casida, PhD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone app (VAD Care App) and Usual LVAD Care in people with Heart Failure, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: Baseline (T0), 1 month (T1), 3 (T2) months, and 6 months post hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.