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N/A N=181 Randomized Treatment

Teleconference Fatigue Management for People With Multiple Sclerosis

Multiple Sclerosis

Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Change From Baseline in Subscale Scores of the Fatigue Impact Scale — -3.74; -1.22; -4.24; -1.11 units on a scale — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Energy conservation education (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Illinois at Chicago
Primary completion
Feb 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Subscale Scores of the Fatigue Impact Scale
-3.74; -1.22; -4.24; -1.11; -8.39; -2.38 <0.05 sig

Summary

Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most disabling symptom. Energy conservation education involves teaching people with MS different strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of the effectiveness of face-to-face energy conservation education, not all people with MS are able to access these programs. The purpose of this project is to test the effectiveness and efficacy of a teleconference-delivered energy conservation education program for people with MS. The primary goals of the project are to reduce the impact of fatigue on participants' everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to increase self-efficacy for managing fatigue and increase the number of energy conservation strategies used. The study will employ a randomly allocated two group time series design with a wait-list control group, which is one type of randomized control trial. A total of 181 people with MS will be recruited through direct mailing and advertising. The program will be delivered by telephone teleconference by a licensed occupational therapist. Outcome measures will be administered over the telephone by a research assistant before and after the program, at three months and at six months. We hypothesize that: (1) individuals in the immediate intervention group achieve better outcomes than individuals in the wait-list control group; (2) the program leads to significant reductions in fatigue impact and fatigue severity, and improved quality of life; and (3) improvements in the outcomes can be maintained over six months.

Eligibility Criteria

Inclusion Criteria

  • a diagnosis of MS
  • 18 years of age or older
  • functional English literacy (i.e., able to read course materials and carry on telephone conservations in English)
  • Fatigue Severity Scale score of 4 or greater
  • Residing in the state of Illinois

Exclusion Criteria

  • Short version - Blessed Orientation Memory Concentration Test - outside of normal range
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00591721). 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.

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