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Teleconference Fatigue Management for People With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcia Finlayson, PhD, University of Illinois
ClinicalTrials.gov Identifier:
NCT00591721
First received: December 26, 2007
Last updated: February 27, 2013
Last verified: February 2013
History of Changes

December 26, 2007
February 27, 2013
November 2007
February 2010   (final data collection date for primary outcome measure)
Change From Baseline in Subscale Scores of the Fatigue Impact Scale [ Time Frame: baseline, 7 weeks (immediate post-intervention) ] [ Designated as safety issue: No ]
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
Reduce the impact of fatigue on participants' everyday lives (as measured by the Fatigue Impact Scale) [ Time Frame: immediately post intervention, 3 months post, and 6 months post ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00591721 on ClinicalTrials.gov Archive Site
Not Provided
Improve quality of life (as measured by the SF-36) [ Time Frame: immediately post intervention, 3 months post, 6 months post ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Teleconference Fatigue Management for People With Multiple Sclerosis
Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
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.
  • 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
    Intervention: Behavioral: Energy conservation education
  • 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.
    Intervention: Behavioral: Energy conservation education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591721
H133G070006
No
Marcia Finlayson, PhD, University of Illinois
University of Illinois
Not Provided
Principal Investigator: Marcia L Finlayson, PhD University of Illinois
University of Illinois
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP