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| Name | Class |
|---|---|
| University of Alberta | OTHER |
| University of Calgary | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS INFoRm group | Experimental | 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. |
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| Usual care control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MS INFoRm | Behavioral | 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia Finlayson, PhD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31238966 | Derived | Finlayson M, Akbar N, Turpin K, Smyth P. A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol. BMC Neurol. 2019 Jun 25;19(1):142. doi: 10.1186/s12883-019-1367-6. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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).
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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.
| Usual Care Control Group | Behavioral | The usual care webpage will contain content from widely available resources about MS fatigue. |
|
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). |
| Edmonton |
| Alberta |
| T6G 2G3 |
| Canada |
| Queen's University | Kingston | Ontario | K7L 3N6 | Canada |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |