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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362541
• Other study ID #: 6020674
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: April 2022
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Usual Care Control Group
The usual care webpage will contain content from widely available resources about MS fatigue.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Queen's University	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Marcia Finlayson	University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Modified Fatigue Impact Scale	21-item scale which assesses the impact of fatigue on daily functioning during the last four weeks.	Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Secondary	Change in the Multiple Sclerosis Self-Efficacy Scale	14-item scale measuring self-efficacy in which respondents rate the degree to which they believe they can overcome challenges.	Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Secondary	Change in the Perceived Deficits Questionnaire	20-item questionnaire assessing perceived cognitive function across the domains most commonly affected in MS: attention, retrospective memory, prospective memory, and planning and organization.	Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Secondary	Change in the Center for Epidemiological Studies Depression Scale	20-item scale which assesses depressive symptomatology.	Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Secondary	Change in the Impact on Participation and Autonomy Questionnaire	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.	Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).