What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include dimethyl fumarate, fingolimod, and natalizumab. Dimethyl fumarate can cause gastrointestinal issues, flushing, and elevated liver enzymes. Fingolimod is associated with headache, elevated liver enzymes, diarrhea, cough, flu-like symptoms, and more serious risks like bradyarrhythmia, macular edema, and increased susceptibility to infections. Natalizumab can lead to infusion-related reactions, increased risk of infections, and a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies for the treatment of Multiple Sclerosis (MS). Glatiramer acetate, an immunomodulator, is indicated for relapsing forms of MS and has shown efficacy in reducing relapse rates and disability progression. Dimethyl fumarate, an oral formulation, significantly reduces relapse rates and new brain lesions. Natalizumab, a monoclonal antibody, is effective in reducing relapse rates and improving quality of life in relapsing MS. Alemtuzumab, another monoclonal antibody, is reserved for highly active MS due to its safety profile. These treatments align with the goals of the Frequent PROM Completion trial, which seeks to enhance patient outcomes through regular monitoring and communication.

What other types of research exist?

Promising novel alternatives for MS patients in 2024 include: 1) Nurse-led, telephone-based patient support programs, which have shown potential in improving adherence and disease management skills. 2) Peginterferon beta-1a, which has demonstrated significant improvements in clinical outcomes and disability endpoints. 3) Oral dimethyl fumarate (BG-12), which has significantly reduced relapse rates and new brain lesions. 4) Fingolimod, which has shown a larger reduction in mfVEP latency compared to interferon beta-1b in preliminary trials.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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.

0 / 5Eligibility criteria met

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.