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

Dr. Marcia Finlayson

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Usual Care Control Group; Behavioral: MS INFoRm

Study type: Interventional

Funder types: Other

Identifiers

NCT03362541

6020674

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 2 patient groups

MS INFoRm group

Experimental group

Description:

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.

Treatment:

Behavioral: MS INFoRm

Usual care control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care Control Group