Multidisciplinary Clinic Care for Heart Failure
(MultiVAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special team approach for caring for individuals with a heart pump (VAD) can improve their quality of life and reduce complications. It will compare new VAD patients who see only the multidisciplinary team (including assessments like cardiopulmonary exercise tests, six-minute walk tests, MoCA, and Quality of Life questionnaires), VAD patients who see both the team and regular doctors, and past patients' records. Participants should have a VAD and be able to perform simple exercises and answer questions about their quality of life. The study seeks to discover if this new care method helps patients feel better and stay healthier. As an unphased trial, it offers a unique opportunity to contribute to innovative care methods that could enhance patient well-being.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this multidisciplinary team care is safe for VAD patients?
Research shows that a team-based approach to care is safe and effective for managing heart conditions, including those requiring a ventricular-assist device (VAD). This team comprises various healthcare professionals who collaborate to provide comprehensive care. This method has improved outcomes in complex heart cases.
The six-minute walk test, part of the team's assessments, offers a simple and reliable way to evaluate patient progress. Studies have safely used it with heart failure patients. Another test, the cardiopulmonary exercise test, assesses heart and lung function during exercise and is also very safe.
Overall, this team-based care and these tests are generally well-tolerated. They aim to improve quality of life without adding significant risk. No reports of serious problems have been linked to these specific methods, making them a safe choice for managing VAD patients.12345Why are researchers excited about this trial?
Researchers are excited about the multidisciplinary clinic care for heart failure because it offers a comprehensive approach that goes beyond standard treatments, such as medication and routine check-ups. This approach involves a team of specialists who work together to provide a more personalized and coordinated care plan. It includes advanced assessments like cardiopulmonary exercise tests and quality of life questionnaires, which can offer deeper insights into a patient's health and recovery process. By integrating these elements, the hope is to improve patient outcomes and overall quality of life for those living with heart failure, setting it apart from conventional treatments that often focus on just one aspect of care.
What evidence suggests that this multidisciplinary team care is effective for improving quality of life in VAD patients?
Research has shown that a team of diverse healthcare professionals can significantly benefit heart failure patients with ventricular-assist devices (VADs). In this trial, some participants will join a prospective interventional cohort receiving multidisciplinary team care, including assessments like the six-minute walk test. Studies have found that involving various healthcare experts in patient care leads to fewer hospital visits and better overall health. For instance, one study found that only 30% of patients with team care were readmitted for heart failure, compared to 60% without it. The six-minute walk test, part of this team care plan, has improved patients' exercise capacity and quality of life. This suggests that team care could enhance the quality of life and reduce stress for caregivers of patients with VADs.678910
Who Is on the Research Team?
Erin Coglianese, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with a ventricular assist device (VAD) implanted. Group A includes new VAD patients who haven't had standard follow-up visits, and Group B includes those who have. Participants must be able to complete physical tests and questionnaires. Caregivers of these patients are also included.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Newly-implanted VAD patients receive multidisciplinary team care, while previously-implanted patients receive a hybrid of MDT and standard-of-care visits
Follow-up
Participants are monitored for safety, quality of life, and functional capacity improvements
Retrospective Data Collection
Retrospective review of historical control cohort data for comparison
What Are the Treatments Tested in This Trial?
Interventions
- Caregiver Self-Assessment
- Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)
Trial Overview
The study compares the effects of multidisciplinary team care versus standard post-implant care on quality of life, caregiver burnout, and functional capacity in VAD patients. It involves exercise tests, walk tests, and questionnaires for both patients and caregivers.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
This cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits.
This cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant.
This cohort will consist of primary caregivers of VAD patients from the two interventional cohorts. They will be administered a questionnaire at two timepoints. Each VAD patient will be associated with only one primary caregiver for the duration of the study.
The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
Multidisciplinary Ventricular Assist Device Clinic (MultiVAD)
The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an ...
Validity and Reliability of the Six-Minute Walking Test ...
The six-minute walk as a safety exercise in improving the health-related quality of life among heart failure patients: A preliminary research.
Outcomes with heart failure management in a ...
At 12 months, 24 patients (60%) in the control group, but only 12 patients (30%) in the intervention group patients had been readmitted for heart failure (p = ...
The 6-Minute Walk Test for Heart Failure: A Powerful Tool ...
The 6-Minute Walk Test for Heart Failure: A Powerful Tool to Track Functional Improvement in Heart Failure Patients · Cardiopulmonary Response ...
Quality of life in heart failure. The heart of the matter. A ...
... assessment of quality of life in heart failure ... The effectiveness of patient‐centered self‐care education for adults with heart failure ...
Six-minute Walk Test and Cardiopulmonary Exercise ...
The 6MWT is confirmed to be a simple and reliable first-line test for quantification of exercise intolerance in patients with HF.
The Multidisciplinary Heart Team in Cardiovascular Medicine
The MDHT team plays a central role in the treatment of a broad array of complex diseases across multiple cardiovascular medicine subspecialties.
2020 ACC/AHA Clinical Performance and Quality ...
This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs.
Safe Passage
The program staff is committed to providing patients with the best evidence based care possible to provide safe and efficient care. Using a team based approach, ...
ATS Statement | Guidelines for the Six-Minute Walk Test
This statement provides practical guidelines for the 6-minute walk test (6MWT). Specifically, it reviews indications, details factors that influence results.
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