Actively Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a structured wellness program can improve the quality of life for adults living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot randomized controlled trial will compare immediate versus delayed start of a multi-modal wellness program tailored to NMOSD patients, involving physical therapists, dietitians, social workers, nurse practitioners, and cognitive therapists. The study aims to assess quality of life using the MS-Quality of Life-54 tool as the primary measurement. Participants will be randomly assigned to either begin the wellness program immediately or after a 6-month delay. The program includes comprehensive evaluations by a dietician, social worker, physical therapist, nurse practitioner, and behavioral neuropsychologist. Follow-up sessions will monitor progress and challenges. After the initial 6-month period, participants may join a one-year extension study with additional wellness interventions and bi-monthly behavioral counseling. Throughout the study, participants will complete surveys and objective assessments at baseline, 12 weeks, 6 months, 12 months, and 18 months to evaluate quality of life, vision, mobility, exercise habits, diet adherence, and motor and vision function. These measures help researchers understand the program's impact and its sustainability over time. The total study duration for those in the extension phase can be up to 18 months.
CONDITIONS
Brief Title
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with NMOSD diagnosed by 2015 clinical criteria
- All levels of disability (EDSS scores) are eligible
- Patients on any treatment type or no treatment are eligible
You will not qualify if you...
- Under 18 years of age
- Unable to provide voluntary consent
- Unable to participate in study assessments or currently enrolled in another randomized controlled trial or wellness intervention
- Relapse within 30 days of randomization
- Medical restrictions on physical activity
- Starting stimulants or dalfampridine between enrollment and randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive wellness program services and behavioral interventions including dietary, physical therapy, social work, nurse practitioner evaluations, and behavioral counseling to implement recommendations.
Initial evaluation at baseline and follow-up evaluations during the 6 months
Duration - Up to 6 months
Participants complete assessments to evaluate quality of life, mobility, vision, exercise, diet, and motor and vision function at 12 weeks and 6 months.
Assessments at 12 weeks and 6 months
Duration - 12 months
Participants may continue in a one-year extension study with one additional wellness intervention and bimonthly behavioral counseling sessions to support sustainability of the wellness program.
One wellness intervention and bimonthly behavioral counseling sessions during the year
Duration - 6 months
Participants complete assessments at 12 months and 18 months to assess the long-term sustainability of the wellness program.
Assessments at 12 months and 18 months
Trial Site Locations
Total: 1 location
1
Corinne Goldsmith Dickinson Center for MS at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Susan Filomena
S
Savannah Steer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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