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PROMs for Multiple Sclerosis Care

N/A
Waitlist Available
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Greater or equal to the age of 18 years old
Persons with multiple sclerosis [relapsing-remitting, secondary progressive, primary progressive, etc.] being managed by a Northern or Central Alberta-based neurologist
Must not have
Under the age of 18
Unwilling/unable to complete the questionnaires
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if regular health surveys shared with doctors can improve mental health and care satisfaction for people with MS. Patients will fill out surveys periodically, and the results will help doctors tailor their care.

Who is the study for?
This trial is for English-speaking adults over 18 with multiple sclerosis (MS) managed by a neurologist in Northern or Central Alberta. Participants must be able to use a computer and willing to complete questionnaires. Those unable to consent, complete the surveys, under 18, or with other central nervous system inflammatory disorders besides MS are excluded.
What is being tested?
The study tests if more frequent reporting of patient feelings and experiences (every 6 months) improves mental health and satisfaction with care compared to less frequent reporting (annually). One group's reports will be shared with their neurologist; the control group's won't.
What are the potential side effects?
Since this trial involves completing questionnaires rather than taking medication, there are no direct physical side effects. However, discussing personal health issues frequently may have emotional impacts on participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have multiple sclerosis and am under the care of a neurologist in Northern or Central Alberta.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I cannot or will not fill out the study questionnaires.
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I have a brain inflammation condition that is not multiple sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Change in Anxiety score in the Hospital Anxiety and Depression Scale (HADS-A) scores
Anxiety
Secondary study objectives
Difference in Change in the Euro Quality of Life Measurement (EQ5D)
Difference in Change in the Modified Fatigue Impact Scale (MFIS) score
Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive PROMs Intervention ArmExperimental Treatment1 Intervention
The intervention group will be asked to complete PROM questionnaires at baseline, 6 months, and 12 months via an online web-based delivery system. The treating neurologist will be prompted to view the text response to the 3-item prompt in addition to the PROM questionnaire scores for participants in the interventional group. Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.
Group II: Control ArmActive Control1 Intervention
The control group will be asked to complete PROM questionnaires at baseline and 12 months via an online web-based delivery system. The treating neurologist will only be prompted to view the text response to the 3-item prompt, and will not be able to access the PROM questionnaire scores for participants in the control group (unless critical values are reached on questionnaires - see below). Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include interferon beta, glatiramer acetate, dimethyl fumarate, fingolimod, and natalizumab. Interferon beta works by modulating the immune response to reduce inflammation and slow disease progression. Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Dimethyl fumarate activates the Nrf2 pathway, providing neuroprotection and reducing oxidative stress. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the central nervous system. Natalizumab blocks the adhesion of immune cells to the blood-brain barrier, reducing their entry into the brain and spinal cord. These treatments are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, thereby improving quality of life.
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
919 Previous Clinical Trials
431,344 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
35,478 Patients Enrolled for Multiple Sclerosis
University Hospital FoundationOTHER
7 Previous Clinical Trials
1,530 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
248 Patients Enrolled for Multiple Sclerosis

Media Library

Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist Clinical Trial Eligibility Overview. Trial Name: NCT04979546 — N/A
Multiple Sclerosis Research Study Groups: Intensive PROMs Intervention Arm, Control Arm
Multiple Sclerosis Clinical Trial 2023: Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist Highlights & Side Effects. Trial Name: NCT04979546 — N/A
Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979546 — N/A
~61 spots leftby Oct 2025