Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, fatigue, self-management, rehabilitation
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.
Interventions
BEHAVIORALMS 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.
BEHAVIORALUsual Care Control Group
The usual care webpage will contain content from widely available resources about MS fatigue.
Sponsors
University of Alberta
University of Calgary
Dr. Marcia Finlayson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Modified Fatigue Impact Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in the Multiple Sclerosis Self-Efficacy Scale | 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 | 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 | 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 | 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. |
Countries
Canada
Outcome results
None listed