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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Usual Care Control Group; Behavioral: MS INFoRm

• Registration Number: NCT03362541
• Lead Sponsor: Dr. Marcia Finlayson

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-05
• Study Start: 2018-01-30
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care control group	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.
MS INFoRm group	MS INFoRm	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.
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.

Trial Locations

Locations (3)

Queen's University; 🇨🇦 Kingston, Ontario, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada