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Completed

NCT Number: NCT03362541

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MS INFoRm

Behavioral

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

Behavioral

The usual care webpage will contain content from widely available resources about MS fatigue.

Primary outcomes

  1. 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

  1. Change in the Multiple Sclerosis Self-Efficacy Scale

    Time frame: 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.

  2. Change in the Perceived Deficits Questionnaire

    Time frame: 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.

  3. Change in the Center for Epidemiological Studies Depression Scale

    Time frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).

    20-item scale which assesses depressive symptomatology.

  4. Change in the Impact on Participation and Autonomy Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Marcia Finlayson

Other

Collaborators

  • University of Alberta
  • University of Calgary

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2017
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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