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A Multi-Site Trial of MS INFoRm (Fatigue Management Resource)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362541
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
University of Alberta
University of Calgary
Information provided by (Responsible Party):
Dr. Marcia Finlayson, Queen's University

Brief Summary:

People with MS commonly experience extreme fatigue that negatively impacts their ability to engage in a full range of daily activities, quality of life, and employment. A new website called MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) allows people with MS to take a personalized and active approach to learning about and managing their fatigue. The aims of this study are:

  1. To determine to determine whether 3-month use of the MS INFoRm website can reduce the impact of fatigue on daily life among persons with MS.
  2. To determine whether 3-month use of the MS INFoRm website results in improvement in self- efficacy/ confidence for managing MS fatigue, self-reported cognitive function, participation and autonomy/ independence, and depression.
  3. To determine whether benefits are maintained among the MS INFoRm users after 6-months.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: MS INFoRm Behavioral: Usual Care Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will use a randomized controlled trial design to test the efficacy and effectiveness of MS INFoRm. Two hundred participants from at least three sites across Canada will be randomly assigned to one of two groups: the experimental (MS INFoRm) group or usual care control group. After completing the study, participants in the usual care control group will be given access to MS INFoRm in order to provide them with any benefits of the website, if any are uncovered. Both groups will be evaluated on primary (fatigue impact) and secondary (self-efficacy, cognitive function, participation and autonomy, depression) outcomes at baseline (week 1), after 3-month use of the MS INFoRm website (week 12), and after 6-month follow-up (week 36).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Both the MS INFoRm group and the control group will receive a login and password, although participants in the groups will be directed to a different webpages (i.e. a MS INFoRm page or usual care control webpage). This will facilitate blinding of participants to their allocation. The research assistant will complete the scheduling, data collection, and data entry blinded to the group allocation.
Primary Purpose: Treatment
Official Title: A Multi-Site Randomized Controlled Trial of MS INFoRm: An Interactive Fatigue Management Resource for Persons With Multiple Sclerosis
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MS INFoRm group
Participants in the MS INFoRm group will be given a login and password that will take them to the MS INFoRm webpage. Access will be granted for 3-months, starting on the date of the first login. Participants can access the website at any time, at their own volition over the 3-months.
Behavioral: MS INFoRm
MS INFoRm incorporates principles of self-management and adult learning theory. The contents address the sources of fatigue, ways of monitoring fatigue, and strategies to reduce fatigue.

Active Comparator: Usual care control group
Participants in the usual care group will be given a login and password that will take them to a usual care webpage. Access will be granted for 3-months, starting on the date of the first login. Participants can access the website at any time, at their own volition over the 3-months.
Behavioral: Usual Care Control Group
The usual care webpage will contain content from widely available resources about MS fatigue.




Primary Outcome Measures :
  1. Change in the Modified Fatigue Impact Scale [ Time Frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). ]
    21-item scale which assesses the impact of fatigue on daily functioning during the last four weeks.


Secondary Outcome Measures :
  1. Change in the Multiple Sclerosis Self-Efficacy Scale [ Time Frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). ]
    14-item scale measuring self-efficacy in which respondents rate the degree to which they believe they can overcome challenges.

  2. Change in the Perceived Deficits Questionnaire [ Time Frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). ]
    20-item questionnaire assessing perceived cognitive function across the domains most commonly affected in MS: attention, retrospective memory, prospective memory, and planning and organization.

  3. Change in the Center for Epidemiological Studies Depression Scale [ Time Frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). ]
    20-item scale which assesses depressive symptomatology.

  4. Change in the Impact on Participation and Autonomy Questionnaire [ Time Frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). ]
    Provides a measure of limitations in participation and autonomy. The tool includes 39 questions across 5 domains: autonomy indoors, autonomy outdoors, family role, social life and relationships, and work and education.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • confirmed diagnosis of MS
  • between 18 and 65 years of age
  • access to a computer or other electronic device with internet access on which to use the website
  • report mild to moderate fatigue
  • live in Canada

Exclusion Criteria:

  • any major comorbid conditions that might influence fatigue management (lupus, rheumatoid arthritis, chronic obstructive lung disease, chronic fatigue syndrome)
  • report difficulty reading and comprehending English written at a Grade 7 level
  • report upper extremity or visual impairments that cannot be accommodated adequately to enable computer access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362541


Contacts
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Contact: Nadine Akbar, PhD 6135336000 ext 77874 nadine.akbar@queensu.ca
Contact: Marcia Finlayson, PhD 6135332576 marcia.finlayson@queensu.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Scott Jarvis, MD, PhD    403-943-8653    scott.jarvis@ahs.ca   
Principal Investigator: Scott Jarvis, MD, PhD         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Penelope Smyth, MD    780-248-1775    smyth@ualberta.ca   
Principal Investigator: Penelope Smyth, MD         
Sub-Investigator: Karen Turpin, MSN         
Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Nadine Akbar, PhD    6135336000 ext 77874    nadine.akbar@queensu.ca   
Principal Investigator: Marcia Finlayson, PhD         
Sub-Investigator: Nadine Akbar, PhD         
Sponsors and Collaborators
Dr. Marcia Finlayson
University of Alberta
University of Calgary
Investigators
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Principal Investigator: Marcia Finlayson, PhD Queen's University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Marcia Finlayson, Vice Dean Health Sciences, Director School of Rehabilitation Therapy, Queen's University
ClinicalTrials.gov Identifier: NCT03362541    
Other Study ID Numbers: 6020674
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Marcia Finlayson, Queen's University:
multiple sclerosis
fatigue
self-management
rehabilitation
Additional relevant MeSH terms:
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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