What is the mechanism of action of this treatment?

Common treatments for Multiple Sclerosis (MS) include dimethyl fumarate (BG-12) and glatiramer acetate. Dimethyl fumarate works by activating the Nrf2 pathway, which reduces oxidative stress and inflammation, while glatiramer acetate modulates the immune system by mimicking myelin basic protein, thereby reducing immune attacks on myelin. These mechanisms are crucial for MS patients as they help to reduce relapse rates, slow disease progression, and manage symptoms. The trial on After Visit Direct Patient Messaging aims to enhance these outcomes by providing structured information on lifestyle modifications, which can further support disease management and improve patients' quality of life.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta-1a, dimethyl fumarate, and fingolimod. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and liver enzyme abnormalities. Dimethyl fumarate is associated with gastrointestinal issues, flushing, and a decrease in white blood cell count. Fingolimod may lead to macular edema, infections, and cardiovascular effects such as bradycardia. These treatments aim to reduce relapse rates and slow disease progression but come with potential side effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies (DMTs) for the treatment of Multiple Sclerosis (MS). Notable among these are interferon beta-1a and beta-1b, which have shown efficacy in reducing relapse rates and MRI lesion volumes. Glatiramer acetate, another DMT, has been effective in lowering relapse rates and disability progression. Oral formulations like dimethyl fumarate (BG-12) have also been approved, demonstrating significant reductions in relapse rates and new brain lesions. These treatments align with the goals of the After Visit Direct Patient Messaging trial, which aims to improve patient outcomes through structured information delivery on physical activity, sleep, and diet.

What other types of research exist?

Promising alternatives to After Visit Direct Patient Messaging for MS patients include: 1) Telehealth consultations, which provide remote access to healthcare professionals and continuous monitoring. 2) Interactive web-based programs, such as relapse management tools, which empower patients with self-management strategies. 3) Integrative treatment projects that combine conventional and alternative therapies, fostering a holistic approach to MS care.

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eHealth Wellness Interventions for Multiple Sclerosis

N/A

Waitlist Available

Led By Ellen Mowry, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-89 years of age

Be older than 18 years old

Must not have

Patients who have opted out of being contacted for MyChart recruitment

Patients who have opted out of being contacted for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if sending messages with wellness tips to MS patients helps them manage their disease better. The messages include advice on exercise, sleep, and diet. Researchers will check if these tips make patients feel more confident and improve their health habits.

Who is the study for?

This trial is for adults aged 18-89 with Multiple Sclerosis who have an active MyChart account, seen at the Johns Hopkins MS Center within a year, and have an upcoming appointment. They must consent to questionnaires and randomization. It's not for those who've opted out of research or MyChart contacts.

What is being tested?

The study tests if direct messages to patients after clinic visits can help them change their behavior regarding physical activity, sleep, and diet. It also looks at how these changes affect their self-efficacy in managing MS and overall patient-reported outcomes.

What are the potential side effects?

Since this trial involves behavioral interventions through messaging rather than medication or medical procedures, there are no typical side effects like you'd expect from drugs; however, participants may experience stress or anxiety related to lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 89 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I chose not to be contacted for studies through MyChart.

Select...

I have chosen not to be contacted for any reason.

Select...

I have chosen not to be contacted for research studies.

Select...

This criterion does not apply to me as I am alive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in self-efficacy as assessed by the MS Self-Efficacy Scale (MSSE)

Secondary study objectives

Change in Diet behavior Scores as assessed by the Mediterranean-DASH Intervention for Neurodegenerative Delay score (MIND Diet score)

Change in Reported physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

Change in Reported physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) short form

+1 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: Wellness SmartphraseExperimental Treatment1 Intervention

This arm will receive a secure message after the conclusion of their standard clinic visit providing a set script containing information on a number of wellness-related topics in MS (sleep, diet, exercise).

Group II: No InterventionActive Control1 Intervention

This arm will not receive a secure message after their appointment, and will instead receive their standard care with their provider.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Wellness Patient Message

2023

N/A

~60

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 dimethyl fumarate (BG-12) and glatiramer acetate. Dimethyl fumarate works by activating the Nrf2 pathway, which reduces oxidative stress and inflammation, while glatiramer acetate modulates the immune system by mimicking myelin basic protein, thereby reducing immune attacks on myelin. These mechanisms are crucial for MS patients as they help to reduce relapse rates, slow disease progression, and manage symptoms. The trial on After Visit Direct Patient Messaging aims to enhance these outcomes by providing structured information on lifestyle modifications, which can further support disease management and improve patients' quality of life.

Current concepts in multiple sclerosis therapy.