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Evaluation of an Online, On Demand Multimodal Wellness Program to Reduce Fatigue and Improve Quality of Life in Progressive Multiple Sclerosis.

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Following informed consent, participants complete a 7-day run-in period designed to assess their ability to complete study procedures and baseline questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an online wellness program can reduce tiredness and improve mood and quality of life over 6 months. It is for adults ages 45 to 70 with progressive multiple sclerosis (MS) and tiredness that affects daily life. People are assigned by chance to start the program right away or continue usual care and get the program after the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have primary or secondary progressive MS, confirmed by your treating nerve specialist using the required diagnosis rules. Your specialist must approve participation.
  • Be 45 to 70 years old when you agree to join.
  • Speak and read English well enough to understand the consent form and talk with study staff.
  • Score at least 4 on the Fatigue Severity Scale, a survey about tiredness.
  • Be able to cook meals at home, or have someone in your household who can.
  • Agree to follow the study diet, 4-7-8 breathing exercise, and planned exercise program.
  • Have high-speed internet and your own device that can play online audio and video.
  • Complete online surveys at the start, at 3 months, and at 6 months.

Who can't join

  • Take insulin or Coumadin, a blood thinner.
  • Have had an MS flare-up, used corticosteroid medicines, or started or changed an MS disease-modifying treatment in the past 4 weeks.
  • Have received radiation or chemotherapy for cancer in the past 12 months.
  • Have significant heart, liver, or kidney disease, or a history of oxalate kidney stones.
  • Have a mental health condition that makes following the study difficult, or an active eating disorder.
  • Have a body mass index (BMI), a measure based on height and weight, below 19.
  • Have started or changed medicine for a mood disorder in the past 12 weeks.
  • Have moderate or severe problems with memory or thinking, shown by 5 or more errors on the study's screening questionnaire.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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. 2. Age 45 to 70 at the time of consent. 3. 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. 4. Fatigue Severity Scale (FSS) score of greater than or equal to 4. 5. Ability to prepare, or availability of someone in the household to prepare, home-cooked meals. 6. Willingness to commit to the study diet, 4-7-8 breathing technique, and a structured exercise program. 7. Access to high-speed internet with ownership of a device that can access the online programming and is capable of audio/video streaming. 8. Completion of online surveys at Month 0 (baseline), Month 3, \& Month 6. Exclusion Criteria: 1. Confirmation of taking insulin or coumadin. 2. Documentation of relapse during the prior 4 weeks. 3. Use of corticosteroids during the prior 4 weeks. 4. Change or initiation of Disease Modifying Treatment (DMT) during the prior 4 weeks. 5. Treatment for cancer by radiation or chemotherapy within the prior 12 months. 6. Diagnosis of clinically significant heart, liver, or kidney disease, or history of oxalate kidney stones. 7. Clinical diagnosis of psychiatric disease making study adherence difficult (e.g., schizophrenia) or an active eating disorder (anorexia, bulimia, binge eating, orthorexia). 8. Measurement of Body Mass Index (BMI) \< 19. 9. Initiation of or change in medication to treat mood disorders in the prior 12 weeks. 10. 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).

Study sites (1)

IA