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

NCT06780709 | Recruiting

• 2 other identifiers: STUDY-23-01257ISRA# 370464
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Keywords

NMOSD; Wellness; Diet; Physical Therapy; Social Work; Comprehensive

Outcome Measures

Primary Outcomes (1)

• Multiple Sclerosis Quality of Life (MSQOL-54) Score

  The MSQOL-54 is a 54-item comprehensive patient-reported questionnaire for individuals with MS. MSQOL-54 yields two main composite scores calculated using weighted averages of relevant areas: Physical Health Composite (PHC) - the physical function, health perceptions, energy/fatigue, role limitations- physical, pain, sexual function, social function, health distress scales. The Mental Health Composite (MHC) - the health distress, overall quality of life, emotional wellbeing, role limitations- emotional, cognitive function scales. Each composite scores range from 0-100, with total scale range from 0-100. Higher scores indicating better perceived health and quality of life. Lower scores suggest poorer quality of life impacted by MS. MSQOL-54 evaluates how MS affects various aspects of a patient's life and well-being, providing valuable insights into the patient's overall health status and the impact of MS on their daily functioning.

  at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

Secondary Outcomes (4)

• Impact of vision impairment (IVI) Score

  at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

• Neuro-Quality of Life (Neuro-QOL) Score

  at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

• The Godin Leisure Time and Exercise (GLTEQ) Score

  at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

• Mediterranean Diet Compliance Scale (MEDAS)

  at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

Study Arms (2)

Immediate Start

EXPERIMENTAL

Participants will begin wellness program services and behavioral interventions immediately after randomization

Behavioral: Wellness Program and Behavioral Counseling

Delayed Start

OTHER

Participants will experience a 6-month delay in receiving wellness program services and behavioral interventions.

Behavioral: Wellness Program and Behavioral Counseling

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.

Delayed Start; Immediate Start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Corinne Goldsmith Dickinson Center for MS at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Health Promotion; Behavior Therapy

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sammita Satyanarayan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Filomena

CONTACT

212-241-3841; susan.filomena@mssm.edu

Savannah Steer

CONTACT

212-241-4264; savannah.steer@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurology

Model Details: Patients will be randomized into two assigned arms of the trial.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)