DEWNCT07831928

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

StatusRecruiting

PhaseNot applicable

SponsorUniversity of Iowa

Primary completionNov 15, 2029 (estimated)

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 11, 2026 Recruitment opened
- Start date pushed from Nov 15, 2026 to Dec 15, 2026
- Eligibility criteria expanded, about 12 words
- Site details revised
Minor Sep 23, 2026 Study description shortened, about 9 words
Sep 15, 2026 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Fatigue Severity Scale (FSS) Score

Timeframe: Baseline to 3 months

Secondary (13)

Fatigue Severity Scale (FSS) Score

Change in Modified Fatigue Impact Scale (MFIS) Score

Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Physical Health Composite Score

Change in MSQOL-54 Mental Health Composite Score

Change in Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)

Show 8 moreShow less

Change in Hospital Anxiety and Depression Scale Depression Subscale (HADS-D) Score

Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score

Change in Physical Activity Vital Sign (PAVS) Weekly Minutes of Moderate-to-Vigorous Physical Activity

Change in Mediterranean Diet Adherence Screener (MEDAS-14) Score

Change in Paleolithic Diet Adherence Screener (PDAS-12) Score

Change in Multiple Sclerosis Self-Efficacy Scale (MSSE) Score

Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score

Patient Determined Disease Steps (PDDS) Score

Arms and interventions

Intervention armExperimental

Wellness online program and virtual exercise platform

Waitlist controlPlacebo comparator

Continues with usual care as directed by their neurologist

Behavioral: Online wellness course and online exercise platform

Other: Usual Care Group

Sites

1 site in 1 country

UI Health CareIowa City, Iowa, United States

About this trial

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.

Trial details

Enrollment: 118 participants (estimated)
Started: Dec 15, 2026
Study completion: Dec 15, 2030 (estimated)
Eligibility: 45 to 70, all sexes, no healthy volunteers
Design: Interventional, randomized, double blind, treatment
Oversight: No data monitoring committee
Conditions: Fatigue, Motor Activity, Multiple Sclerosis, Chronic Progressive, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS)
Official title: 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)
First posted: Sep 21, 2026
Registry updated: Nov 12, 2026
Last verified: Nov 2026

Related trials at risk

View on ClinicalTrials.gov ↗