Autoimmune Intervention Mastery Course Study

Study Overview
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Brief Summary
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The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, and post acute sequela of covid

Detailed Description
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The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, and post acute sequela of covid. Once eligibility criteria are determined and consent is obtained, participants would work through the course modules like a non-graded online course. There are exercises and personal assessments within the course participants are asked to take to build upon each other to increase the success of the experience while taking the course. Throughout the course there will be modules that will discuss an inner game plan, food intervention plan, physical intervention plan, and an increased resilience plan. The fourth module suggests different strategies that participants can do to improve their health beyond food and exercise. These types of things would include supplements, light therapy, detoxification, improved sleep, stress reduction, and other ways to enhance their body's resilience. Investigators ask that participants inform and work with their healthcare team to personalize their treatment and determine if the suggested strategies mentioned in the course are appropriate for their healthcare path. This will provide dietary education to a larger sample size compared to what has been studied in the past. The study may include more patients that have limited resources, including but not limited to, money and location for access to registered dietitians with expertise in dietary instruction for patient s diagnosed with multiple sclerosis and CIS. There is interest in education and support that can be delivered via an online platform that can lead to improved diet quality and self-care routines for multiple sclerosis and autoimmune patients. This study will use a randomized single-blind wait list control design to evaluate the impact of an online course that teaches the modified Paleolithic diet, nutrient dense vegetarian diet and Mediterranean diets, stress reduction and exercise strategies using commercially available online course for autoimmune patients. Data will be collected in the short-term (after 3 months) and long-term (at the end of 6 months ) to analyze the impact of an online wellness program QoL and related outcomes among people with CIS and MS. The study will use a 7-day window to collect baseline assessments. Participants will use a personal email that does not contain identifying information to participate in the study. Participants will be asked to complete all baseline assessments. This email and password will be used for access to the online course materials. Patients will be randomized to the intervention arm based upon the baseline modified fatigue impact score. Patients will receive access to the online program and 7 group support videos (released one per week or 7 weeks total). Participants will access the course materials using the study assigned email. The proposed study will consist of virtual-only participants and will have 3 virtual visits every 3 months (months 0, 3, and 6). Online questionnaires will be sent to the participants to assess fatigue and quality of life. Dietary assessments will include a questionnaire through a web-based tool after baseline, at month 3, and month 6.

Official Title
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Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia, Post Acute Sequelae of COVID-19

Intervention / Treatment
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* Behavioral: Immediate Autoimmune Intervention Mastery Course (AIM)
* Behavioral: Immediate Question and Answer sessions. (AIM Q and A sessions)
* Behavioral: Delayed Autoimmune Intervention Mastery Course (delayed AIM course)
* Behavioral: Delayed AIM Question and Answer sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-reported multiple sclerosis self-reported clinically isolated syndrome OR self-reported post-acute sequelae of COVID (PASC), also known as long COVID, with a confirmed laboratory test of COVID-19 infection, persisting fatigue and neuropsychiatric symptoms for longer than 6 months after confirmation of COVID diagnosis, OR self-reported diagnosis of fibromyalgia as documented by their treating specialist or primary care provider, Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Wait list control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Autoimmune Intervention Mastery Course (AIM) online course<br>This arm will begin the intervention immediately after randomization | Behavioral: Immediate Autoimmune Intervention Mastery Course (AIM)<br>* Immediate access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care<br>* Other names: AIM course;Behavioral: Immediate Question and Answer sessions. (AIM Q and A sessions)<br>* Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.<br>* Other names: AIM Q and A sessions;|
| Other: Delayed Autoimmune Intervention Mastery Course<br>This is the control arm. | Behavioral: Delayed Autoimmune Intervention Mastery Course (delayed AIM course)<br>* Delayed access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care<br>Behavioral: Delayed AIM Question and Answer sessions<br>* Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.<br>* Other names: Delayed AIM Q and A sessions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 3 months | 
| Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 6months | 
| Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 3 months | 
| Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 6 months | 
| Short form 36 (SF 36) | Change in (SF 36) survey questions mean scores, range 0-100, higher number is better. | baseline to 3 months | 
| Short form 36 (SF 36) | Change in (SF 36) survey questions mean scores, range 0-100, higher number is better. | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Impact Scale | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 3 months | 
| Modified Fatigue Impact Scale | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 6 months | 
| vegetable and fruit intake | Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more | baseline to 3 months | 
| vegetable and fruit intake | Change in number of servings of vegetables consumed per day, servings range from 0 to 9 or more | baseline to 6 months | 
| added sugar intake | change in the grams of added sugar consumed each day, grams range from 0 to 100 | baseline to 3 months | 
| added sugar intake | change in the grams of added sugar consumed each day, grams range from 0 to 100 | baseline to 6 months | 
| calcium intake | change in calcium intake, range 0 to 2000 mg | baseline to 3 months | 
| calcium intake | change in calcium intake, range 0 to 2000 mg | baseline to 6 months | 
| Servings of whole grains consumed | change in number of servings of whole grains consumed, range 0 to 6 or more servings | baseline to 3 months | 
| Servings of whole grains consumed | change in number of servings of whole grains consumed, range 0 to 6 or more servings | baseline to 6 months | 
| Fibromyalgia Impact Questionnaire Revised | Pain Rating (0-10 Low to High Scale) with higher score indicating greater impact | baseline to 3 months | 
| Fibromyalgia Impact Questionnaire Revised | Pain Rating (0-10 Low to High Scale)15 items with higher score indicating greater impact | baseline to 6 months | 
| Brief Pain Inventory | Interference (0-10 Low to High Scale) 15 items with higher score indicating greater intensity | baseline to 3 months | 
| Brief Pain Inventory | Range 0-10( Low to High Scale) with higher score indicating greater pain intensity | baseline to 6 months | 
| FM Disease activity (FIQR) | 0-100( Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia. | baseline to 3 months | 
| FM Disease activity (FIQR) | 0-100 (Low to High Scale)21 items used to evaluate function, overall impact, and symptoms in patients with fibromyalgia. High score indicating more severe symptoms. | baseline to 6 months | 
| Pain scale | 0-10 (low to high) 13 items used to evaluate feelings about pain. | baseline to 3 months | 
| Pain catastrophizing scale | 052 (low to high) 13 items used to evaluate feelings about pain. Higher scores indicating more severe feelings about pain related problems | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, self care