The Use of Technology to Improve MS Clinical Trials and Patient Care (NCT02454907) | Clinical Trial Compass
CompletedNot Applicable
The Use of Technology to Improve MS Clinical Trials and Patient Care
United States150 participantsStarted 2018-07-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.