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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06780709
Status
Recruiting
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Conditions

  • Neuromyelitis Optica Spectrum Disorder (NMOSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wellness Program and Behavioral Counseling — BEHAVIORAL
    The comprehensive wellness evaluation will include initial assessments by dietician, social worker, physical therapist, nurse practitioner, and a behavioral neuropsychologist. Each provider will conduct an initial evaluation at baseline to identify areas of need and patient driven goals, as well as follow-up evaluations to evaluate implementation of changes and barriers to change.

Study Details

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.

Key Dates

Start date
Jan 21, 2025
Status verified
Apr 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Immediate Start
    Participants will begin wellness program services and behavioral interventions immediately after randomization
  • Other: Delayed Start
    Participants will experience a 6-month delay in receiving wellness program services and behavioral interventions.

Primary Outcome Measure

Multiple Sclerosis Quality of Life (MSQOL-54) Score [ Time Frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corinne Goldsmith Dickinson Center for MS at Mount SinaiNew YorkNew York10029
Sammita Satyanarayan (PRINCIPAL_INVESTIGATOR)
Ilana Katz-Sand, MD (SUB_INVESTIGATOR)

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By research site
Corinne Goldsmith Dickinson Center for MS at Mount Sinai· New York, NY

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