Teleconference Fatigue Management for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591721
• Other study ID #: H133G070006
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: February 27, 2013
• Start date: November 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2013
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Energy conservation education
The intervention for this study is a group-based educational program delivered by teleconference to 4-6 individuals with MS by a licensed occupational therapist. The program involves 6 weekly sessions. Each session is 1 hour and 15 minutes in duration. Key topics addressed include: importance of rest, positive and effective communication, modification of the environment, using equipment and technology, setting priorities, and activity analysis and modification. Direct instruction, group discussion, and peer support are key elements of the program. Participants receive a manual with application activities that are completed in between sessions.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Subscale Scores of the Fatigue Impact Scale	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	baseline, 7 weeks (immediate post-intervention)	No