Multiple SclerosisNCT03362541
A Multi-Site Trial of MS INFoRm (Fatigue Management Resource)
A study testing MS INFoRm in people with Multiple Sclerosis, run by Dr. Marcia Finlayson at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MS INFoRm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 3 sitesCanada
- Study dates
- 30 Jan 2018to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Canada3 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta, T6G 2G3
Queen's University
Kingston, Ontario, K7L 3N6
About this study
Official title: 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:
- 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.
- 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.
- To determine whether benefits are maintained among the MS INFoRm users after 6-months.
- Conditions
- Multiple Sclerosis
- Being tested
- MS INFoRm, Usual Care Control Group
- Keywords
- multiple sclerosis, fatigue, self-management, rehabilitation
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS INFoRmBehavioural
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 GroupBehavioural
The usual care webpage will contain content from widely available resources about MS fatigue.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Modified Fatigue Impact Scale
21-item scale which assesses the impact of fatigue on daily functioning during the last four weeks.
Measured: 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
14-item scale measuring self-efficacy in which respondents rate the degree to which they believe they can overcome challenges.
Measured: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Change in the Perceived Deficits Questionnaire
20-item questionnaire assessing perceived cognitive function across the domains most commonly affected in MS: attention, retrospective memory, prospective memory, and planning and organization.
Measured: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Change in the Center for Epidemiological Studies Depression Scale
20-item scale which assesses depressive symptomatology.
Measured: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Change in the Impact on Participation and Autonomy Questionnaire
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.
Measured: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start30 Jan 2018
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Marcia Finlayson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Calgary
- Responsible party
- Sponsor-investigator, Dr. Marcia Finlayson, Queen's University
- Investigators
- Marcia Finlayson, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362541
- Sponsor's protocol ID
- 6020674
- Status last verified
- Apr 2022
- First submitted
- 20 Nov 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31238966
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Randomized Controlled Trial of MS INFoRm: An Interactive Fatigue Management Resource for Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03362541
- Acronym / sponsor ID
- 6020674
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, self-management, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Dr. Marcia FinlaysonUniversity, hospital or other
- Collaborators
- University of Alberta, University of Calgary
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To determine whether benefits are maintained among the MS INFoRm users after 6-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| MS INFoRm group | Experimental | Behavioral: MS INFoRmParticipants 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. |
| Usual care control group | Active comparator | Behavioral: Usual Care Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS INFoRmMS 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. | Behavioural | MS INFoRm group |
| Usual Care Control GroupThe usual care webpage will contain content from widely available resources about MS fatigue. | Behavioural | Usual care control group |
Primary outcome
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.
4 secondary outcomes
Change in the Multiple Sclerosis Self-Efficacy Scale
Time frame: 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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 31238966Finlayson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Finlayson, PhD principal investigator
Queen's University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS INFoRm in people with Multiple Sclerosis, run by Dr. Marcia Finlayson at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Modified Fatigue Impact Scale (time frame: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.