Do Video Recordings of Multidisciplinary Clinics Improve Quality of Life for People With ALS and Their Caregivers?

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrustees of Dartmouth College

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Video recording
  • Notes Instruction

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Trustees of Dartmouth College

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Massachusetts General Hospital

Collaborator

Dartmouth-Hitchcock Medical Center

Collaborator

University of Pittsburgh Medical Center

Collaborator

Penn State Health Milton S Hershey Medical Center

Collaborator

University of Wisconsin, Madison

Collaborator

Mayo Clinic

Collaborator