The Use of Technology to Improve MS Clinical Trials and Patient Care

NCT ID: NCT02454907

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2026-01-31

Brief Summary

Many patients with multiple sclerosis (MS) experience "relapses" of disease activity during which they have increased numbness, weakness, visual problems, or other symptoms. If a person with MS has new symptoms that are concerning to them, their doctor may want to see them in the office in order to confirm that these symptoms are due to a true "relapse" of activity before starting relapse treatment. This requirement can be frustrating for patients, who may have to take time off from work or travel long distances for such unexpected doctors' visits. In this study, the investigators will use input from patients with MS and MS physicians to create a relapse questionnaire that can be used to confirm a relapse has occurred. The investigators will also evaluate if having a more direct line of communication with the provider's office improves overall patient care and satisfaction.

Detailed Description

This research is being done to study if a relapse questionnaire for people with multiple sclerosis (MS) may help more easily determine if a relapse has occurred.

A further goal of this study is to determine if receiving periodic messages from the doctor's office, as well as having the direct contact information of a person in the office, improves the care of the patients and their experience thereof.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Control

One kind of communication with the clinic will be used.

Group Type: ACTIVE_COMPARATOR

Communication with the clinic

Intervention Type: OTHER

Over the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office.

Experimental

A different kind of communication with the clinic will be used.

Group Type: EXPERIMENTAL

Communication with the clinic

Intervention Type: OTHER

Over the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office.

Interventions

Communication with the clinic

Over the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• English speakers
• Relapsing-remitting MS (2010 criteria)
• Expanded Disability Status Scale (EDSS) ≤6.0
• Possession of a smartphone OR of a mobile telephone with text messaging AND an e-mail account AND web access OR willingness to be provided with, and utilize, a smartphone for the duration of the study
• In the two years before screening:

at least two relapses, OR one relapse and two new lesions (unrelated to relapse symptoms) on magnetic resonance imaging (MRI), OR RRMS (MAGNIMS 2010 criteria) onset within the past year with no exposure to disease modifying therapies (DMT)

• Patient is starting one of the following MS therapies: injectable (subcutaneous interferon beta or glatiramer acetate) or oral (fingolimod, teriflunomide, or dimethyl fumarate) therapies
• Relapse and MRI activity occurred while untreated or despite one single treatment, and no change in therapy since that activity
• Lives within 100 miles of Johns Hopkins Medical Center (Baltimore, MD)

Exclusion Criteria

• History of DMT exposure if MAGNIMS 2010 criteria used to enroll patients with disease onset in the past year, or change in MS therapy since qualifying relapse/MRI criteria occurred

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Mowry

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00083614

Identifier Type: -

Identifier Source: org_study_id