Video Recordings for ALS
(VITALS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States. The gold standard of care for people with ALS is multidisciplinary clinics (MDC). In these multidisciplinary clinics, which occur every 3 to 4 months, people with ALS see up to 12 different healthcare providers (e.g., speech therapy, physical therapy, the ALS doctor). These clinics can last from three to five hours, and across these three to five hours people with ALS and their caregivers receive a lot of information that is critical to the care and quality of life for people with ALS. However, this information can be difficult to remember given the large amount of information that is conveyed. The current standard for providing take-home information about the visit is to provide patients with a written after-visit summary and access to their doctor's notes about the visit, typically through the patient portal. This study tests whether providing participants with video recordings of their MDC visits improves their quality of life and the quality of life of their caregivers. The study will enroll 400 pairs of people with ALS and their caregivers from eight different sites in the United States. Half of the participants in the study will receive their after-visit summary notes (the NOTES condition) and the other half of the participants will receive both their summary notes, but will also receive video recordings of their MDC visits that they can watch on their own at home (the VIDEO condition). The study will last for 12 months, with participants receiving NOTES or VIDEO at each of their regularly-scheduled MDCs during the 12 months. The study will test whether caregiver and patient participants in the VIDEO condition experience better quality of life than those in the NOTES condition at 1 month, 6 months, and 12 months from study enrollment. The results of this study will help determine what is the most effective approach to communicating MDC information to people with ALS and their caregivers.
Who Is on the Research Team?
Suma Babu, MD
Principal Investigator
Massachusetts General Hospital
Paul J Barr, PhD
Principal Investigator
Dartmouth College
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants attend multidisciplinary clinics every 3 months, receiving either NOTES or VIDEO interventions
Follow-up
Participants are monitored for quality of life and adherence to treatment recommendations
What Are the Treatments Tested in This Trial?
Interventions
- Video Recording
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this arm of the study will have their multidisciplinary clinic visits video recorded and they will be able to access those video recordings on their own at home. They will also be able to access their doctor's notes and after visit summaries through their patient portal.
Participants in this arm of the study will have their standard access to their doctor's notes and after visit summaries through their patient portal. They will also be provided with training on how to access and share access to their patient portal notes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trustees of Dartmouth College
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Massachusetts General Hospital
Collaborator
University of Pittsburgh Medical Center
Collaborator
University of Wisconsin, Madison
Collaborator
Mayo Clinic
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
Penn State Health Milton S Hershey Medical Center
Collaborator
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