Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Short form 36 (SF 36)
研究概览
简要总结
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, post acute sequela of covid, and cancer in remission with persisting fatigue.
详细描述
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, post acute sequela of covid, and cancer in remissin with persisting fatigue. The cancer patients must be patients at the University of Iowa Holden Cancer Center.
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, fibromyalgia, post acute sequela of covid, and cancer in remission wiht persisting fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Investigator will be masked.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- 未提供
研究组 & 干预措施
Intervention Autoimmune Intervention Mastery Course (AIM) online course
This arm will begin the intervention immediately after randomization
干预措施: Immediate Question and Answer sessions. (AIM Q and A sessions) (Behavioral)
Intervention Autoimmune Intervention Mastery Course (AIM) online course
This arm will begin the intervention immediately after randomization
干预措施: Immediate Autoimmune Intervention Mastery Course (AIM) (Behavioral)
Delayed Autoimmune Intervention Mastery Course
This is the control arm.
干预措施: Delayed Autoimmune Intervention Mastery Course (delayed AIM course) (Behavioral)
Delayed Autoimmune Intervention Mastery Course
This is the control arm.
干预措施: Delayed AIM Question and Answer sessions (Behavioral)
结局指标
主要结局
Short form 36 (SF 36)
时间窗: baseline to 6 months
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
时间窗: baseline to 6 months
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
时间窗: baseline to 6months
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
时间窗: baseline to 6 months
FACIT-FS is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, which can be completed in less than 5 minutes.10 Each question provides 5 ordinal response options ("not at all," "a little bit," "somewhat," "quite a bit," and "very much"). Each item contributes equally (item score range=0-4) to a total score that ranges from 0 to 52, where higher scores represent less fatigue.
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
时间窗: baseline to 3 months
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
时间窗: baseline to 3 months
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.
Short form 36 (SF 36)
时间窗: baseline to 3 months
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.
The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):
时间窗: baseline to 3 months
FACIT-FS is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, which can be completed in less than 5 minutes.10 Each question provides 5 ordinal response options ("not at all," "a little bit," "somewhat," "quite a bit," and "very much"). Each item contributes equally (item score range=0-4) to a total score that ranges from 0 to 52, where higher scores represent less fatigue.
次要结局
- Modified Fatigue Impact Scale(baseline to 6 months)
- Brief Pain Inventory(baseline to 6 months)
- FM Disease activity (FIQR)(baseline to 6 months)
- calcium intake(baseline to 6 months)
- Pain scale(baseline to 3 months)
- Servings of whole grains consumed(baseline to 6 months)
- Fibromyalgia Impact Questionnaire Revised(baseline to 6 months)
- Pain catastrophizing scale(baseline to 6 months)
- vegetable and fruit intake(baseline to 6 months)
- added sugar intake(baseline to 6 months)
- Functional Assessment of Cancer Therapy - General (FACT-G)(baseline to 6 months)
- Modified Fatigue Impact Scale(baseline to 3 months)
- vegetable and fruit intake(baseline to 3 months)
- added sugar intake(baseline to 3 months)
- calcium intake(baseline to 3 months)
- Servings of whole grains consumed(baseline to 3 months)
- Fibromyalgia Impact Questionnaire Revised(baseline to 3 months)
- Brief Pain Inventory(baseline to 3 months)
- FM Disease activity (FIQR)(baseline to 3 months)
- Functional Assessment of Cancer Therapy - General (FACT-G)(baseline to 3 months)
- Optional interview at study conclusion(collected at study conclusion)
研究者
Terry L. Wahls
Clinical professor
University of Iowa