The Sean M. Healey & AMG Center for Integrated ALS Care and Discovery and the Dartmouth Geisel School of Medicine Announce First Participant Enrolled in VITALS Trial
The Sean M. Healey & AMG Center for ALS and Dartmouth’s Geisel School of Medicine are pleased to announce that the first participant has enrolled in the Video Integration to Traditional Amyotrophic Lateral Sclerosis (VITALS) trial (ClinicalTrials.gov Identifier: NCT07454733). We would like to thank Mark Garret, MD, Site Principal Investigator at Dartmouth Health’s Dartmouth Hitchcock Medical Center and his team for achieving this important milestone.
The VITALS trial is a multi-site, effectiveness-implementation, hybrid, randomized controlled trial. This trial will evaluate the impact of providing full-length, chapterized video recordings of clinician encounters during a multidisciplinary ALS clinic visit. The trial’s objectives are to determine whether access to these recordings improves quality of life and optimizes care delivery for people living with ALS and their caregivers. The trial will enroll about 400 people living with ALS and their 400 caregivers across eight sites in the United States.
In this trial, participants are randomized into two groups. One group receives training on how to access and use the written patient portal summaries (NOTES) of their multidisciplinary clinic visits, which is the current standard of care for ALS, and the second group receives this training plus video recordings (VIDEO) of visits for 12 months. Participants in the VIDEO group have access to video recordings via HealthPAL, a HIPAA-compliant digital application developed by dual PI Barr at Dartmouth.
The trial is led by Suma Babu, MBBS, MPH, Co-Director of the Neurological Clinical Research Institute (NCRI) at Mass General Brigham and Associate Professor at Harvard Medical School, and Paul Barr, PhD, MPH, Professor of Health Policy & Clinical Practice at the Geisel School of Medicine and a member of Dartmouth’s Center for Technology and Behavioral Health.
“Recruiting our first patient and caregiver dyad to this trial is a major milestone, reflecting the diligent work of our research teams across the country,” says Dr. Barr. “I am especially proud that our patient and caregiver partners—people directly affected by ALS—have contributed so meaningfully to the successful launch of this study. We are also incredibly grateful to the patients and clinical teams who have given us the opportunity to be part of their journey.”
“We are excited to start the VITALS trial to learn more about how to improve quality of life and care for people living with ALS and their caregivers,” says Dr. Babu, “It can be difficult to retain all information provided in multidisciplinary clinics because people living with ALS meet with several healthcare providers in just one visit. This trial will hopefully help us find more effective ways of communicating information.”
The VITALS trial is enrolling at eight sites across the United States, including Mayo Clinic Scottsdale in Scottsdale, Ariz.; Mayo Clinic Jacksonville in Jacksonville, Fla.; Massachusetts General Hospital in Boston, Mass.; Dartmouth Hitchcock Medical Center in Lebanon, N.H.; Columbia University Irving Medical Center in New York, N.Y.; Penn State Health Milton S. Hershey Medical Center in Hershey, Pa.; University of Pittsburgh Medical Center in Pittsburgh, Pa.; and the University of Wisconsin Health in Madison, Wis. To learn more, please visit ClinicalTrials.gov.
Media contact
Brandon Chase
External Communications Specialist
bchase7@mgb.org
About the Sean M. Healey & AMG Center for Integrated ALS Care and Discovery at Mass General Brigham
At the Sean M. Healey & AMG Center for ALS at Mass General Brigham, we are committed to bringing together a global network of scientists, physicians, nurses, foundations, federal agencies, and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development. Launched in November 2018, the Healey & AMG Center, under the leadership of Merit Cudkowicz, MD and a Science Advisory Council of international experts, is reimagining how to develop and test the most promising therapies to treat the disease, identify cures and ultimately prevent it.
With many clinical trials and lab-based research studies in progress right now, we are ushering in a new phase of ALS treatment and care. Together, we will find the cures.
About the Neurological Clinical Research Institute
The Neurological Clinical Research Institute (NCRI) at Mass General Brigham is an academic research organization composed of innovative researchers experienced and passionate about designing, developing, facilitating, and conducting multicenter clinical trials in neurological diseases. Our mission is to accelerate translational research in neurological disorders by initiating clinical development of novel therapies and leading trials of these compounds. We strive to be at the cutting edge of innovative trial design to accelerate therapy development by creating new trial methodology, discovering novel biomarkers and refining outcome measures.