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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Wellness Program and Behavioral Counseling
  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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Impact of vision impairment (IVI) Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study]
• Mediterranean Diet Compliance Scale (MEDAS) [Срок оценки: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Corinne Goldsmith Dickinson Center for MS at Mount Sinai — New York

Идентификаторы

NCT: NCT06780709 · STUDY-23-01257 · ISRA# 370464

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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