Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis (ALS) Visit Communication on Patient and Caregiver Quality of Life (VITALS trial): Design of a Randomized Controlled Trial
Taravat Yazdanian1, Mark Garret2, Kelly Goedert3, Renata West Yen3, Reed Bratches4, Zachary Simmons5, Paul Barr3, Suma Babu6
1Neurology, Massachusetts General Hospital, 2Neurology, Dartmouth Hitchcock Medical Center, 3Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth, 4The University of Alabama at Birmingham, 5Neurology, Penn State Hershey Medical Center, 6Massachusetts General Hospital, Brigham, Harvard
Objective:
Determine the comparative effectiveness of written summaries (NOTES) of multidisciplinary clinic (MDC) visits versus notes plus video recordings (VIDEO) on quality of life for people living with Amyotrophic Lateral Sclerosis (pwALS) and their caregivers. 

Background:
The MDC is the gold standard of care delivery for pwALS. However, less than 40% of the recommendations made during these four to five-hour-long visits are recalled by pwALS and their caregivers. Emerging research shows that audiovisual recording of doctors’ visits enhances recall of recommendations and self-management of chronic conditions. Results from a single-site pilot showed that MDC visit recording was feasible and well-accepted by pwALS and clinicians. 

Design/Methods:

VITALS is an eight-site effectiveness-implementation hybrid randomized controlled trial in which 400 dyads (pwALS+caregiver) are randomized to either NOTES or VIDEO and followed for 12 months. For their MDC visits, those in NOTES receive instructions on accessing summaries through the patient portal, and those in VIDEO receive patient portal notes plus video recordings via HealthPAL, a HIPAA-compliant app/website. Principal inclusion criteria are diagnosis of ALS, expected survival ≥ 12 months, and presence of a non-professional caregiver. The primary outcome is quality of life for pwALS (ALS Assessment Questionnaire, ALSAQ-40) and caregivers (PROMIS-10). Secondary outcomes include self-management, adherence, and caregiver burden/preparedness. The analytic plan follows an intent-to-treat principle and involves separate analyses for pwALS and caregivers, regressing the comparator (VIDEO vs NOTES) on each outcome while accounting for the effects of site. Patients, caregivers, and stakeholder partners are involved in steering the design and implementation of the trial. 


Results:

Protocol development is underway. IRB approval and site activation are anticipated in Quarter 2 of 2026, with first participant enrollment expected in the summer of 2026.


Conclusions:

The results will inform best practices for the communication of visit information for individuals with complex and chronic health conditions such as ALS. 

10.1212/WNL.0000000000217217
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.