Clinical trial NCT03362541: A Multi-Site Trial of MS INFoRm (Fatigue Management Resource)
Official title: A Multi-Site Randomized Controlled Trial of MS INFoRm: An Interactive Fatigue Management Resource for Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
fatigue
self-management
rehabilitation
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: University of Calgary
First posted: 2017-12-05
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in the Modified Fatigue Impact Scale
timeFrame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Secondary outcomes:
measure: Change in the Multiple Sclerosis Self-Efficacy Scale
timeFrame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
measure: Change in the Perceived Deficits Questionnaire
timeFrame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
measure: Change in the Center for Epidemiological Studies Depression Scale
timeFrame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
measure: Change in the Impact on Participation and Autonomy Questionnaire
timeFrame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Marcia Finlayson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.