Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Quality of Life (MSQOL-54) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Immediate Start
Participants will begin wellness program services and behavioral interventions immediately after randomization
干预措施: Wellness Program and Behavioral Counseling (Behavioral)
Delayed Start
Participants will experience a 6-month delay in receiving wellness program services and behavioral interventions.
干预措施: Wellness Program and Behavioral Counseling (Behavioral)
结局指标
主要结局
Multiple Sclerosis Quality of Life (MSQOL-54) Score
时间窗: 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.
次要结局
- 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)
研究者
Sammita Satyanarayan
Assistant Professor, Neurology
Icahn School of Medicine at Mount Sinai