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

April 18, 2022 updated by: Dr. Marcia Finlayson

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University Of Calgary
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MS INFoRm group
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.
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.
Active Comparator: 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.
Behavioral: Usual Care Control Group
The usual care webpage will contain content from widely available resources about MS fatigue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
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.
Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
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.
Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
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.
Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Marcia Finlayson

Collaborators

University of Alberta
University of Calgary

Investigators

  • Principal Investigator: Marcia Finlayson, PhD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6020674

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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