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

NCT ID: NCT03362541

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2021-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

MS INFoRm

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Usual Care Control Group

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care Control Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role collaborator

Dr. Marcia Finlayson

OTHER

Sponsor Role lead

Responsible Party

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Dr. Marcia Finlayson

Vice Dean Health Sciences, Director School of Rehabilitation Therapy

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcia Finlayson, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31238966 (View on PubMed)

Other Identifiers

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6020674

Identifier Type: -

Identifier Source: org_study_id

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