Teleconference Fatigue Management for People With Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT00591721
• Recruitment Status: Completed
• First Posted: January 11, 2008
• Results First Posted: February 28, 2013
• Last Update Posted: February 28, 2013
• Sponsor: University of Illinois at Chicago
• Information provided by (Responsible Party): Marcia Finlayson, PhD, University of Illinois at Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Behavioral: Energy conservation education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis
• Study Start Date: November 2007
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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.
Wait list control; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Subscale Scores of the Fatigue Impact Scale [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Illinois at Chicago

Investigators

• Principal Investigator: Marcia L Finlayson, PhD; University of Illinois at Chicago

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Marcia Finlayson, PhD, Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT00591721
• Other Study ID Numbers: H133G070006
• First Posted: January 11, 2008
• Results First Posted: February 28, 2013
• Last Update Posted: February 28, 2013
• Last Verified: February 2013

Keywords provided by Marcia Finlayson, PhD, University of Illinois at Chicago:

energy conservation education; occupational therapy intervention; fatigue management; psychoeducation

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Fatigue; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases