Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists. The trial will be designed as a randomized controlled trial, randomizing patients to immediately starting the program as well as a 6 month delayed start. The intervention would leverage an existing clinical comprehensive MS wellness program at the Corinne Dickinson for Multiple Sclerosis (MS) at Mount Sinai Medical Center. The primary endpoint of this study would be evaluating quality of life, as assessed by MS-Quality of Life -54.
Eligibility criteria
Qualifiers
Adults (age ≥18) with NMOSD diagnosed with 2015 NMOSD clinical criteria.
All EDSS scores will be considered in order to make the intervention accessible to all patients regardless of disability.
All patients regardless of treatment type will be considered.
Disqualifiers
Age<18
Inability to voluntarily provide consent for study participation
Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention.
Any patients with a relapse within 30 days of randomization or any patients with medical restrictions on physical activity will be excluded.
Trial design
Treatments tested in this trial
- Wellness Program and Behavioral Counseling
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov