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

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ClinicalTrials.gov Identifier: NCT02454907
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Communication with the clinic Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Use of Technology to Improve MS Clinical Trials and Patient Care
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
One kind of communication with the clinic will be used.
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.

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




Primary Outcome Measures :
  1. Blinded [ Time Frame: 96 weeks ]
    The primary and secondary outcomes for this study are blinded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454907


Contacts
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Contact: Ellen Mowry 4106141522 mscenter@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jen Chalayon       ochalay1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Ellen Mowry Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02454907     History of Changes
Other Study ID Numbers: NA_00083614
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases