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

Dr. Marcia Finlayson3 sites in 1 country161 target enrollmentJanuary 30, 2018

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Dr. Marcia Finlayson
Enrollment: 161
Locations: 3
Primary Endpoint: Change in the Modified Fatigue Impact Scale
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 30, 2018

End Date

June 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr. Marcia Finlayson

Responsible Party

Sponsor Investigator

Principal Investigator

Dr. Marcia Finlayson

Vice Dean Health Sciences, Director School of Rehabilitation Therapy

Queen's University

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

Outcomes

Primary Outcomes

Change in the Modified Fatigue Impact Scale

Time Frame: 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 Outcomes

Change in the Center for Epidemiological Studies Depression Scale(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
Change in the Multiple Sclerosis Self-Efficacy Scale(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
Change in the Impact on Participation and Autonomy Questionnaire(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
Change in the Perceived Deficits Questionnaire(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)