Clinical trial NCT06780709: Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Official title: Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)
Keywords: NMOSD
Wellness
Diet
Physical Therapy
Social Work
Comprehensive
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into two assigned arms of the trial.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This pilot will aim to recruit 20 patients. Participants will be randomized into one of two arms: the trial group will begin wellness program services and behavioral interventions immediately; the control group will participate in other educational activities, and begin wellness program services and behavioral interventions 6 months after randomization. The wellness intervention will include dietary, physical therapy, social work, and nurse practitioner evaluations, as well as behavioral counseling to implement recommendations. All participants will complete assessments, with patient-reported outcome surveys and objective assessments at baseline, 12 weeks, and 6 months for the core study. Participants will also be offered the option of continuing into a one year extension study, wherein one additional wellness intervention and bimonthly behavioral counseling sessions will be offered until 12 months on study. Study assessments will be completed at 12 months and 18 months to assess sustainability of the program. Assessments will include subjective reports of quality of life as pertaining to living with their disease, mobility, vision, exercise, diet, as well as objective measures of motor and vision function.

Eligibility criteria: 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.

Primary outcomes:
measure: Multiple Sclerosis Quality of Life (MSQOL-54) Score
timeFrame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Secondary outcomes:
measure: Impact of vision impairment (IVI) Score
timeFrame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
measure: Neuro-Quality of Life (Neuro-QOL) Score
timeFrame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
measure: The Godin Leisure Time and Exercise (GLTEQ) Score
timeFrame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
measure: Mediterranean Diet Compliance Scale (MEDAS)
timeFrame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
Other outcomes:
Locations:
city: New York
country: United States
facility: Corinne Goldsmith Dickinson Center for MS at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sammita Satyanarayan, MD
role: PRINCIPAL_INVESTIGATOR
References: