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

Sponsor

Dr. Marcia Finlayson (Other)

Overall Status

Completed

CT.gov ID

NCT03362541

Collaborator

University of Alberta (Other), University of Calgary (Other)

161

Enrollment

Locations

Arms

40.5

Actual Duration (Months)

53.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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:

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

161 participants

Allocation:

Randomized

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).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.

Primary Purpose:

Treatment

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 :

Jan 30, 2018

Actual Primary Completion Date :

Jun 15, 2021

Actual Study Completion Date :

Jun 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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