Evaluation of an Online, On Demand Multimodal Wellness Program to Reduce Fatigue and Improve Quality of Life in Progressive Multiple Sclerosis: A Randomized Waitlist Controlled Trial (DEW Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale (FSS) Score
研究概览
简要总结
The goal of this clinical trial is to learn if an online wellness program can lower fatigue and improve mood and quality of life in people with progressive multiple sclerosis who are 45 to 70 years old and are experiencing significant fatigue disability.
The main questions it aims to answer are:
- Does the online wellness program lower fatigue after 3 months and further lower fatigue after 6 months?
- Does the online wellness program improve anxiety, depression, and quality of life after 3 months and lead to additional improvements after 6 months? Researchers will compare participants who receive immediate access to the online wellness program with participants who continue their usual care and receive access to the program after the study ends.
Participants will:
- Complete online surveys at the start of the study, at 3 months, and at 6 months. Each survey session takes less than 1 hour.
- Complete a 7-day run-in period before randomization to confirm their interest and ability to complete study activities.
- Be assigned by chance to either the online wellness program group or the wait-list control group.
Participants in the online wellness program group will:
- Receive access to the "Creating Health" online course through the University of Iowa Canvas platform.
- Work through five self-paced education modules over 6 months. Topics include nutrition, stress management, and physical activity.
- Have access to monthly group coaching calls by Zoom.
- Have access to an online exercise platform.
- Have access to email and text support from the study team.
Participants in the wait-list control group will:
- Continue their usual diet, lifestyle, and medical care during the 6-month study period.
- Complete the same study surveys as the intervention group.
- Receive full access to the online wellness program, online exercise platform and support materials after completing their final 6-month surveys.
At the end of the study, all participants will complete final surveys about their symptoms, quality of life, and their experience with the program. Active study participation ends after the 6-month assessments are completed.
详细描述
Detailed Description Multiple sclerosis (MS) is a chronic neurodegenerative disease that affects nearly one million individuals in the United States. Progressive forms of the disease, including Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS), account for approximately 400,000 cases and are associated with substantial disability, fatigue, reduced quality of life, impaired mobility, mood disturbances, and cognitive challenges. Existing disease-modifying therapies have demonstrated effectiveness in reducing inflammatory disease activity but have limited impact on common disabling symptoms such as fatigue, anxiety, depression, and reduced health-related quality of life.
Observational studies and preliminary intervention trials suggest that lifestyle factors, particularly diet quality, physical activity, and stress management practices, may improve symptoms and quality of life in people living with MS. However, high-quality randomized controlled trials evaluating integrated multimodal wellness interventions in individuals with progressive MS remain limited. This gap is particularly important because individuals with PPMS and SPMS often face barriers to in-person rehabilitation and wellness programs due to mobility limitations, transportation challenges, bowel and bladder dysfunction, and residence in rural communities.
The purpose of the Evaluation of an Online, On demand Multimodal Wellness Program to Reduce Fatigue and Improve Quality of Life in Progressive Multiple Sclerosis: A Randomized Waitlist controlled Trial (DEW Study) is to evaluate the effectiveness of a fully online, on-demand multimodal wellness intervention designed to reduce fatigue and improve quality of life among adults with progressive multiple sclerosis with significant fatigue disability. The intervention combines dietary education, structured exercise programming, stress management training, and behavioral support delivered through accessible virtual platforms.
The DEW intervention consists of three primary components:
- Creating Health Online Wellness Course
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definitive diagnosis of Primary Progressive MS (PPMS) or Secondary Progressive MS (SPMS) based on the 2024 revised McDonald Criteria and confirmed by the treating neurologist who also approves participation.
- •Age 45 to 70 at the time of consent.
- •Must be fluent in both speaking and reading English.
- •*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call.
- •Fatigue Severity Scale (FSS) score of greater than or equal to
- •Ability to prepare, or availability of someone in the household to prepare, home-cooked meals.
- •Willingness to commit to the study diet, 4-7-8 breathing technique, and a structured exercise program.
- •Access to high-speed internet with ownership of a device that can access the online programming and is capable of audio/video streaming.
- •Completion of online surveys at Month 0 (baseline), Month 3, & Month 6.
排除标准
- •Confirmation of taking insulin or coumadin.
- •Documentation of relapse during the prior 4 weeks.
- •Use of corticosteroids during the prior 4 weeks.
- •Change or initiation of Disease Modifying Treatment (DMT) during the prior 4 weeks.
- •Treatment for cancer by radiation or chemotherapy within the prior 12 months.
- •Diagnosis of clinically significant heart, liver, or kidney disease, or history of oxalate kidney stones.
- •Clinical diagnosis of psychiatric disease making study adherence difficult (e.g., schizophrenia) or an active eating disorder (anorexia, bulimia, binge eating, orthorexia).
- •Measurement of Body Mass Index (BMI) <
- •Initiation of or change in medication to treat mood disorders in the prior 12 weeks.
- •Documentation of moderate or severe mental impairment (greater than or equal to 5 errors) as measured by the validated Short Portable Mental Health Questionnaire (SPMHQ).
研究组 & 干预措施
Intervention arm
Wellness online program and virtual exercise platform
干预措施: Online wellness course and online exercise platform (Behavioral)
Waitlist control
Continues with usual care as directed by their neurologist
干预措施: Usual Care Group (Other)
结局指标
主要结局
Fatigue Severity Scale (FSS) Score
时间窗: Baseline to 3 months
The Fatigue Severity Scale (FSS) is a 9-item patient-reported questionnaire that measures the impact and severity of fatigue on daily functioning. Participants rate each item on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items. Higher scores indicate greater fatigue severity. An FSS score ≥4 is commonly used to identify clinically significant fatigue in multiple sclerosis
次要结局
- Fatigue Severity Scale (FSS) Score(Baseline to 6 months)
- Change in Modified Fatigue Impact Scale (MFIS) Score(Baseline to month 3 and month 6.)
- Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Physical Health Composite Score(Baseline to month 3 and month 6)
- Change in MSQOL-54 Mental Health Composite Score(Baseline to month 3 and month 6)
- Change in Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)(Baseline to month 3 and month 6)
- Change in Hospital Anxiety and Depression Scale Depression Subscale (HADS-D) Score(Baseline to month 3 and month 6)
- Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score(Baseline to month 3 and month 6)
- Change in Physical Activity Vital Sign (PAVS) Weekly Minutes of Moderate-to-Vigorous Physical Activity(Baseline to month 3 and month 6)
- Change in Mediterranean Diet Adherence Screener (MEDAS-14) Score(Baseline to month 3 and month 6)
- Change in Paleolithic Diet Adherence Screener (PDAS-12) Score(Baseline to month 3 and month 6)
- Change in Multiple Sclerosis Self-Efficacy Scale (MSSE) Score(Baseline to month 3 and month 6)
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score(Baseline to month 3 and month 6)
- Patient Determined Disease Steps (PDDS) Score(Baseline to month 3 and month 6)
研究者
Terry L. Wahls
Clinical Professor of Medicine
University of Iowa