N/A
N=590
Fatigue Management Programs for People With MS
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03550170 ↗Enrolled (actual)
590
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change From Baseline in Fatigue Levels — 50.98; 56.88; 57.87 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Teleconference (Behavioral); Internet (Behavioral); 1-to-1, in-person or videoconference (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fatigue Levels |
50.98; 56.88; 57.87 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life: Psychological Composite |
40.93; 38.66; 37.77 | 0.10 |
Summary
This is a multi-site randomized clinical trial comparing 3 modes of delivering the Managing Fatigue course for reducing fatigue in individuals with multiple sclerosis (MS). The primary hypothesis is that the teleconference and internet versions of the course will be noninferior to the one-on-one, in person version in terms of the primary outcome of fatigue and secondary outcome of quality of life.
Eligibility Criteria
Inclusion Criteria
- Self-report diagnosis of MS
- Age ≥ 18 years
- Fatigue Severity Scale score ≥ 4
- Ability to speak English
Exclusion Criteria
- Individual must be capable of providing consent (Assessed with questionnaire)
- Unable to access the internet or unable to travel to in-person sessions
Data sourced from ClinicalTrials.gov (NCT03550170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.