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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02454907
• Other study ID #: NA_00083614
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: October 31, 2025

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blinded	The primary and secondary outcomes for this study are blinded.	96 weeks