NCT03362541

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. 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. 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. 3.To determine whether benefits are maintained among the MS INFoRm users after 6-months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

3.4 years

First QC Date

November 20, 2017

Last Update Submit

April 18, 2022

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisfatigueself-managementrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in the Multiple Sclerosis Self-Efficacy Scale

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

  • Change in the Perceived Deficits Questionnaire

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

  • Change in the Center for Epidemiological Studies Depression Scale

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

  • Change in the Impact on Participation and Autonomy Questionnaire

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

Study Arms (2)

MS INFoRm group

EXPERIMENTAL

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

Usual care control group

ACTIVE COMPARATOR

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

Interventions

MS INFoRmBEHAVIORAL

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.

MS INFoRm group
Usual Care Control GroupBEHAVIORAL

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

Usual care control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • Finlayson M, Akbar N, Turpin K, Smyth P. A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol. BMC Neurol. 2019 Jun 25;19(1):142. doi: 10.1186/s12883-019-1367-6.

    PMID: 31238966DERIVED

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marcia Finlayson, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Both the MS INFoRm group and the control group will receive a login and password, although participants in the groups will be directed to a different webpages (i.e. a MS INFoRm page or usual care control webpage). This will facilitate blinding of participants to their allocation. The research assistant will complete the scheduling, data collection, and data entry blinded to the group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will use a randomized controlled trial design to test the efficacy and effectiveness of MS INFoRm. Two hundred participants from at least three sites across Canada will be randomly assigned to one of two groups: the experimental (MS INFoRm) group or usual care control group. After completing the study, participants in the usual care control group will be given access to MS INFoRm in order to provide them with any benefits of the website, if any are uncovered. Both groups will be evaluated on primary (fatigue impact) and secondary (self-efficacy, cognitive function, participation and autonomy, depression) outcomes at baseline (week 1), after 3-month use of the MS INFoRm website (week 12), and after 6-month follow-up (week 36).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Dean Health Sciences, Director School of Rehabilitation Therapy

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 5, 2017

Study Start

January 30, 2018

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)