Do Video Recordings of Multidisciplinary Clinics Improve Quality of Life for People With ALS and Their Caregivers?
VITALS
Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis Visit Communication on Patient and Caregiver Quality of Life
1 other identifier
interventional
800
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
Study Completion
Last participant's last visit for all outcomes
October 1, 2029
March 6, 2026
February 1, 2026
3.3 years
February 25, 2026
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
For Caregiver Participants: the total score on the PROMIS-10 self report survey
The Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) is a self-report measure of quality of life. The PROMIS-10 will be administered to caregivers via a secure online survey. We will analyze the total score on the PROMIS-10 as the primary outcome for caregiver participants.
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
For Patient Participants: The total score on the ALSAQ-40 self report survey.
The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) is a self-report measure of quality of life for people with ALS. The ALSAQ-40 will be administered via a secure online survey.
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
Secondary Outcomes (8)
Total Score on the Patient Activation Measure Short Form (PAM-SF)
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
Total Score on the Exercise Adherence Rating Scale (EARS)
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
Total Score on the Adherence to Refills and Medications Scale (ARMS)
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
Total Score on the Adherence to Multidisciplinary Clinic Recommendations
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
Total Score on the Interpersonal Processes of Care (IPC) Survey
Administered at enrollment (baseline) and 1 month, 6 months, and 12 months after enrollment.
- +3 more secondary outcomes
Other Outcomes (2)
Total number of patient phone calls and patient portal messages to the clinical care team.
From enrollment to 12 months after enrollment.
Total number of emergency room visits and hospitalizations.
From enrollment to 12 months after enrollment.
Study Arms (2)
VIDEO
EXPERIMENTALParticipants 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.
NOTES
ACTIVE COMPARATORParticipants 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.
Interventions
We will video record participants' multidisciplinary clinic (MDC) visits for 12 months. Participants will access the videos in HealthPAL, an NIH-funded, HIPAA-compliant personal health library developed with older adults and caregivers, available in Spanish and English. Each specialist visited with during the MDC will have a 'chapter' in HealthPAL that can be reviewed online at home by participants. Participants will receive orientation and training on both their patient portal and HealthPAL, including how to review and share their recordings using a take-home manual (an instructions video is also available in HealthPAL).
Participants will be given instruction on how to view their after-visit summaries and doctors' notes in their patient portal, as well as how to give other trusted family members or friends access to their visit notes.
Eligibility Criteria
You may qualify if:
- Diagnosis of ALS by either El- Escorial or Gold Coast Criteria
- ≥18 years of age
- Plan to attend MDC visits for 12 months
- Speak English or Spanish
- Presence of a caregiver (defined as someone who assists with care) who is also participating in the VITALS trial
- Projected life expectancy of at least 12 months as determined by the site investigator.
You may not qualify if:
- Unable or unwilling to provide informed consent or follow study procedures
- Significant cognitive impairment, clinical dementia, or unstable psychiatric illness (including, but not limited to, psychosis, active suicidal ideation, suicide attempt, or untreated major depression) as determined by the site investigator
- Current pregnancy based on participant self-report;
- Unable to access the internet;
- Do not have access to a personal or shared email and are not interested in creating a personal or shared email;
- Do not wish to create a patient portal account, if they do not already have one;
- Uncorrected hearing or visual impairment that would impair the ability to view video recordings;
- Incarcerated.
- Agree to their identified role as a caregiver of a patient with ALS participating in the VITALS trial;
- Speak English or Spanish;
- ≥18 years of age.
- Unable or unwilling to provide consent or follow study procedures;
- Unable to access the internet;
- Do not have access to a personal or shared email and are not interested in creating a personal or shared email;
- Uncorrected hearing or visual impairment;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trustees of Dartmouth Collegelead
- Patient-Centered Outcomes Research Institutecollaborator
- Massachusetts General Hospitalcollaborator
- Dartmouth-Hitchcock Medical Centercollaborator
- University of Pittsburgh Medical Centercollaborator
- Penn State Health Milton S Hershey Medical Centercollaborator
- University of Wisconsin, Madisoncollaborator
- Mayo Cliniccollaborator
Study Sites (7)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Massachusetts General Hospital
Boston, Massachusetts, 021114, United States
Dartmouth-Hitchcock Health
Lebanon, New Hampshire, 03756, United States
Penn State Health Milton S. Hersey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Wisconsin Health
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul J Barr, PhD
Dartmouth College
- PRINCIPAL INVESTIGATOR
Suma Babu, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 6, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
October 1, 2029
Last Updated
March 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- We anticipate IPD data being available for sharing within 1 year of the study close (September 2031) in perpetuity.
- Access Criteria
- Data will be stored in a secured data archive. Access to the data will be restricted and available only upon request from researchers with a clear research plan for the data, whom have IRB approval, and the training and resources to carry out the research plan.
Deidentified non-video data that will be shared include demographic data (e.g., age, gender, language, race, ethnicity, income); information on use of the patient portal and video recordings; researcher field notes (e.g., if a caregiver is present at a visit, whether the visit was telehealth or in-person); participant-reported survey responses (e.g., assessments measuring cognitive function, health literacy, quality of life, adherence, self-management ability, caregiver burden, caregiver preparedness). We will also share raw video recordings of the participants' multidisciplinary clinic visits. Raw video recordings will not be accompanied by personal identifying information, but they will not be stripped of any visual or auditory features that could potentially identify an individual.