Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD

ID#: NCT06780709

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: January 21, 2025

End Date: January 01, 2028

Contact Information:
Susan Filomena
212-241-3841
Savannah Steer
212-241-4264
Summary: 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:

Inclusion criteria:

- 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.

Exclusion criteria:

- 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.

- Any patients who begin stimulants and/or dalfampridine between enrollment and randomization will be excluded.
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