Clinical trial NCT00591721: Teleconference Fatigue Management for People With Multiple Sclerosis
Official title: Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: energy conservation education
occupational therapy intervention
fatigue management
psychoeducation
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Subscale Scores of the Fatigue Impact Scale
timeFrame: baseline, 7 weeks (immediate post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Marcia L Finlayson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finlayson M, Preissner K, Cho C, Plow M. Randomized trial of a teleconference-delivered fatigue management program for people with multiple sclerosis. Mult Scler. 2011 Sep;17(9):1130-40. doi: 10.1177/1352458511404272. Epub 2011 May 11.
citation: Finlayson M, Preissner K, Cho C. Outcome moderators of a fatigue management program for people with multiple sclerosis. Am J Occup Ther. 2012 Mar-Apr;66(2):187-97. doi: 10.5014/ajot.2012.003160.