Back to resultsThe Use of Technology to Improve MS Clinical Trials and Patient Care
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication with the clinic
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis
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
Sites / Locations
- Johns Hopkins UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
One kind of communication with the clinic will be used.
A different kind of communication with the clinic will be used.
Outcomes
Primary Outcome Measures
Blinded
The primary and secondary outcomes for this study are blinded.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02454907
Brief Title
The Use of Technology to Improve MS Clinical Trials and Patient Care
Official Title
The Use of Technology to Improve MS Clinical Trials and Patient Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
One kind of communication with the clinic will be used.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
A different kind of communication with the clinic will be used.
Intervention Type
Other
Intervention Name(s)
Communication with the clinic
Intervention Description
Over the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office.
Primary Outcome Measure Information:
Title
Blinded
Description
The primary and secondary outcomes for this study are blinded.
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Mowry
Phone
4106141522
Email
mscenter@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Mowry
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Harris
Email
sharr141@jhmi.edu
12. IPD Sharing Statement
Learn more about this trial
The Use of Technology to Improve MS Clinical Trials and Patient Care
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