- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00591721
Teleconference Fatigue Management for People With Multiple Sclerosis
February 27, 2013 updated by: Marcia Finlayson, PhD, University of Illinois at Chicago
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, 7 weeks (immediate post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marcia L Finlayson, PhD, University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
First Posted (Estimate)
January 11, 2008
Study Record Updates
Last Update Posted (Estimate)
February 28, 2013
Last Update Submitted That Met QC Criteria
February 27, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H133G070006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Energy conservation education
-
Danielle MockensturmUniversity of ToledoWithdrawnBreast Cancer | FatigueUnited States
-
Queensland University of TechnologyNot yet recruitingQuality of Life | Fatigue | End Stage Kidney Disease
-
East Carolina UniversityCompleted
-
Lawson Health Research InstituteCompletedChronic Pain | FibromyalgiaCanada
-
Groupe Hospitalier du HavreCompletedChronic Obstructive Pulmonary DiseaseFrance
-
University of PittsburghU.S. Army Medical Research and Development CommandCompletedFatigue | Traumatic Brain Injury
-
University of CalgaryCompletedQuality of Life | Kidney Diseases | Fatigue | Rehabilitation | Renal DialysisCanada
-
The Hong Kong Polytechnic UniversityRecruitingPsychological Distress | Physiological Stress | COVID-19 Stress SyndromeHong Kong
-
Dalhousie UniversityCompleted
-
Children's Hospital of Chongqing Medical UniversityChengdu Women's and Children's Central Hospital; Kunming Children's Hospital; Nestle Health Science and other collaboratorsNot yet recruitingMalnutrition, Child | Nutritional Deficiency | Malnourishment | UndernutritionChina