RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-21
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06780709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (age ≥18) with NMOSD diagnosed with 2015 NMOSD clinical criteria.
  2. * All EDSS scores will be considered in order to make the intervention accessible to all patients regardless of disability.
  3. * All patients regardless of treatment type will be considered.
  1. * Age\<18
  2. * Inability to voluntarily provide consent for study participation
  3. * Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention.
  4. * Any patients with a relapse within 30 days of randomization or any patients with medical restrictions on physical activity will be excluded.
  5. * Any patients who begin stimulants and/or dalfampridine between enrollment and randomization will be excluded.

Contacts and Locations

Study Contact

Susan Filomena
CONTACT
212-241-3841
susan.filomena@mssm.edu
Savannah Steer
CONTACT
212-241-4264
savannah.steer@mssm.edu

Principal Investigator

Sammita Satyanarayan, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Corinne Goldsmith Dickinson Center for MS at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Sammita Satyanarayan, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-21
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-01-21
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Neuromyelitis Optica Spectrum Disorder (NMOSD)