Teleconference Fatigue Management for People With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Energy conservation education

• Registration Number: NCT00591721
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-08-19
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-27
• Last Update Submitted: 2013-02-27
• Results First Posted: 2013-02-28
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

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Exclusion Criteria

• Short version - Blessed Orientation Memory Concentration Test - outside of normal range

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Energy conservation education	Energy conservation education	Participants received 6-70 minute group teleconference sessions with an occupational therapist facilitator. The intervention provided education, guided discussion, and peer support for learning about and applying energy conservation principles
Wait list control	Energy conservation education	Participants received 6-70 minute group teleconference sessions with an occupational therapist facilitator. The intervention provided education, guided discussion, and peer support for learning about and applying energy conservation principles.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Subscale Scores of the Fatigue Impact Scale	baseline, 7 weeks (immediate post-intervention)	Fatigue impact was measured using the "Fatigue Impact Scale (FIS)" (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants' responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States