Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60612


Purpose:

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.


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


Study is Available At:


Original ID:

H133G070006


NCT ID:

NCT00591721


Secondary ID:


Study Acronym:


Brief Title:

Teleconference Fatigue Management for People With Multiple Sclerosis


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Illinois


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

190


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marcia L Finlayson, PhD
Principal Investigator
University of Illinois

Study Dates

Start Date:November 2007
Completion Date:February 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 27, 2013
First Received Date:December 26, 2007
First Results Date:August 19, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change From Baseline in Subscale Scores of the Fatigue Impact Scale
Time Frame:baseline, 7 weeks (immediate post-intervention)
Safety Issues:False
Description: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 f

Study Interventions

Intervention Type:Behavioral
Name:Energy conservation education
Description: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 disc
Arm Name:Energy conservation education

Study Arms

Study Arm Type:Experimental
Arm Name:Energy conservation education
Description: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
Study Arm Type:Other
Arm Name:Wait list control
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Illinois

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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. Epub 2011 May 11.
PMID:21561960

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.