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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Site Randomized Controlled Trial of MS INFoRm: An Interactive Fatigue Management Resource for Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: MS INFoRm
* Behavioral: Usual Care Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MS INFoRm group<br>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<br>* 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.<br>|
| Active Comparator: Usual care control group<br>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<br>* The usual care webpage will contain content from widely available resources about MS fatigue.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Multiple Sclerosis Self-Efficacy Scale | 14-item scale measuring self-efficacy in which respondents rate the degree to which they believe they can overcome challenges. | Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). | 
| Change in the Perceived Deficits Questionnaire | 20-item questionnaire assessing perceived cognitive function across the domains most commonly affected in MS: attention, retrospective memory, prospective memory, and planning and organization. | Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). | 
| Change in the Center for Epidemiological Studies Depression Scale | 20-item scale which assesses depressive symptomatology. | Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). | 
| Change in the Impact on Participation and Autonomy Questionnaire | 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. | Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, fatigue, self-management, rehabilitation