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Abstract Details

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
Neuromuscular and Clinical Neurophysiology (EMG)
P10 - Poster Session 10 (8:00 AM-9:00 AM)
9-012
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. 
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. 

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. 

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.

The results will inform best practices for the communication of visit information for individuals with complex and chronic health conditions such as ALS. 
Authors/Disclosures
Taravat Yazdanian, MBBS
PRESENTER 		Dr. Yazdanian has nothing to disclose.
Mark Garret, MD Dr. Garret has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Advarra. The institution of Dr. Garret has received research support from Biogen. The institution of Dr. Garret has received research support from Target ALS. The institution of Dr. Garret has received research support from uniQure. The institution of Dr. Garret has received research support from Mass General Brigham. The institution of Dr. Garret has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Garret has received research support from NIH/NINDS. Dr. Garret has received research support from FDA. Dr. Garret has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant with Massachusetts Department of Health.
Kelly M. Goedert, PhD Dr. Goedert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Diehl Consulting Group.
Renata Yen, PhD An immediate family member of Dr. Yen has stock in Civicom, Inc.
Reed W. Bratches, PhD Dr. Bratches has nothing to disclose.
Zachary Simmons, MD, FAAN (Penn State Hershey Med Center) Dr. Simmons has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amylyx. Dr. Simmons has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clene. Dr. Simmons has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Insmed. Dr. Simmons has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Simmons has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Corcept. The institution of Dr. Simmons has received personal compensation in the range of $50,000-$99,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. The institution of Dr. Simmons has received research support from MGH. The institution of Dr. Simmons has received research support from Clene. The institution of Dr. Simmons has received research support from NIH via MGH. The institution of Dr. Simmons has received research support from Aburo. The institution of Dr. Simmons has received research support from NIH subaward via Univ of Pennsylvania.
Paul Barr (Geisel School of Medicine at Dartmouth) No disclosure on file
Suma Babu, MD, MPH (Massachusetts General Hospital, Brigham, Harvard) The institution of Dr. Babu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. The institution of Dr. Babu has received personal compensation in the range of $0-$499 for serving as a Consultant for Specific Biologics. The institution of Dr. Babu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure Therapeutics. The institution of Dr. Babu has received research support from Biogen. The institution of Dr. Babu has received research support from Ionis. The institution of Dr. Babu has received research support from OrphAI therapeutics. The institution of Dr. Babu has received research support from Denali Therapeutics. The institution of Dr. Babu has received research support from Tiziana. Dr. Babu has a non-compensated relationship as a Appointed Member of the Committee on ALS: Accelerating Treatments and Improving Quality of Life with National Academies of Sciences, Engineering and Medicine that is relevant to AAN interests or activities.