Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Wellness Program and Behavioral Counseling
BehavioralThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Immediate StartExperimental treatment 1 intervention
Group B: Delayed StartOther 1 intervention
Trial outcomes
Primary outcomes
1
Multiple Sclerosis Quality of Life (MSQOL-54) Score
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.
Time frame
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension studySecondary outcomes
1
Impact of vision impairment (IVI) Score
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.
Time frame
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study2
Neuro-Quality of Life (Neuro-QOL) Score
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.
Time frame
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study3
The Godin Leisure Time and Exercise (GLTEQ) Score
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.
Time frame
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study4
Mediterranean Diet Compliance Scale (MEDAS)
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.
Time frame
at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension studySponsors and contacts
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Source ClinicalTrials.gov