A Multi-Site Trial of MS INFoRm (Fatigue Management Resource)
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|ClinicalTrials.gov Identifier: NCT03362541|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : February 20, 2020
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:
- 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.
- 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Nadine Akbar, PhD||6135336000 ext email@example.com|
|Contact: Marcia Finlayson, PhDfirstname.lastname@example.org|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N 4N1|
|Contact: Scott Jarvis, MD, PhD 403-943-8653 email@example.com|
|Principal Investigator: Scott Jarvis, MD, PhD|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2G3|
|Contact: Penelope Smyth, MD 780-248-1775 firstname.lastname@example.org|
|Principal Investigator: Penelope Smyth, MD|
|Sub-Investigator: Karen Turpin, MSN|
|Kingston, Ontario, Canada, K7L 3N6|
|Contact: Nadine Akbar, PhD 6135336000 ext 77874 email@example.com|
|Principal Investigator: Marcia Finlayson, PhD|
|Sub-Investigator: Nadine Akbar, PhD|
|Principal Investigator:||Marcia Finlayson, PhD||Queen's University|