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.
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.
Fatigue Severity Scale (FSS) score of greater than or equal to 4.
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.
Crossover
Online wellness course and online exercise platform
BehavioralAn online wellness course that teaches participants about behavior change, nutrition, exercise, stress management, and other wellness behaviors. Also includes access to an online exercise platform.
Usual Care Group
Other interventionParticipant will continue with their usual diet and wellness behaviors.
Fatigue Severity Scale (FSS) Score
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
Fatigue Severity Scale (FSS) Score
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
Change in Modified Fatigue Impact Scale (MFIS) Score
The MFIS evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning during the previous 4 weeks. Score Range: 0 to 84 Interpretation: Lower scores indicate less impact of fatigue. Higher scores indicate greater fatigue-related impairment. A decrease in score represents improvemen
Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Physical Health Composite Score
The MSQOL-54 is a disease-specific quality-of-life measure that combines the SF-36 with MS-specific domains. The Physical Health Composite measures the impact of MS on physical functioning and health. Score Range: 0 to 100 Interpretation: Higher scores indicate better physical health-related quality of life. An increase in score represents improvement.
Change in MSQOL-54 Mental Health Composite Score
The Mental Health Composite of the MSQOL-54 assesses emotional well-being, cognitive health, social functioning, and mental health status. Score Range: 0 to 100 Interpretation: Higher scores indicate better mental health-related quality of life. An increase in score represents improvement
Theoretical Framework of Acceptability (TFA) Questionnaire
The TFA Questionnaire evaluates participant perceptions of intervention acceptability, including burden, perceived effectiveness, ethicality, self-efficacy, and overall satisfaction. Score Range: 1 to 5 per item (summary score calculated as mean response) Interpretation: Higher scores indicate greater acceptability of the intervention.
Process Evaluation Questionnaire (PEQ)
The PEQ is a study-specific questionnaire used to identify facilitators and barriers to participation, as well as participant experiences with intervention delivery and adherence. Score Range: Varies by item Interpretation: Descriptive measure used to assess implementation, feasibility, and participant feedback. Higher scores on scaled items generally indicate more favorable perceptions of the intervention.
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