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NCT Number: NCT06780709

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

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.

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD) Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corinne Goldsmith Dickinson Center for MS at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Ilana Katz-Sand, MD

SUB_INVESTIGATOR

Sammita Satyanarayan

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Impact of vision impairment (IVI) Score

    Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

    The Impact of Vision Impairment (IVI) is a 32-item patient-reported instrument measuring vision impairment's effect on quality of life and daily activities. The questionnaire assesses five domain subscales: Leisure and Work, Social and Consumer Interaction, Household and Personal Care, Mobility, and Emotional Reaction to Vision Loss. Items use a 6-point Likert scale (0: Not at all, 1: Hardly at all, 2: A little, 3: A fair amount, 4: A lot, 5: Can't do because of eyesight). Domain subscale scores are calculated as the mean of items within each domain, and the total score is the mean of all items. Subscales range from 0-5, with total scale range from 0-5. Lower scores indicating better vision-related quality of life. A decrease in scores represents improvement over time.

  2. Neuro-Quality of Life (Neuro-QOL) Score

    Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

    Neuro QOL (quality of life) subscales indicating upper extremity function, lower extremity function, executive function, ability to participate in social roles/activities, satisfaction with social roles and activities) will be assessed. Scores are assessed and compared to normative data, with a T score generated. T distributions assume a mean of 50, and the standard deviation is set to 10 units. A higher T score value indicates a greater deviation from normal functioning.

  3. The Godin Leisure Time and Exercise (GLTEQ) Score

    Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

    The GLTEQ is a patient reported scale assessing patient reported frequency of exercise in a typical 7-day period during their free time. Total Scale is weighted to calculate a composite score from 0-99, with a higher score indicating a more active lifestyle.

  4. Mediterranean Diet Compliance Scale (MEDAS)

    Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study

    MEDAS questionnaire is a self-reported recall of food consumption. This is a 14-item questionnaire, with each item being scored as a 0 or 1 indicating consumption of the specified category of food, with a total scale range of 0-14. A higher score indicates a higher alignment with a mediterranean based diet.

Study contacts

Contact information is provided by the study sponsor or research team.

Savannah Steer

CONTACT

[email protected]

212-241-4264

Susan Filomena

CONTACT

[email protected]

212-241-3841

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Acronym: NMOSD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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