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Can a Nurse's coaching get MS patients to speak up about drug side effects?

NCT ID NCT04116424

Knowledge-focused Sponsor: University Hospital, Caen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

People with multiple sclerosis often do not report side effects from their oral disease-modifying drugs, which leaves safety monitoring incomplete. This trial compares two ways of encouraging reports: a nurse who trains the patient and follows up by phone over six months, versus a neurologist who presents the mobile app during a consultation. Researchers measure how many patients in each group report at least one side effect through the app.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nurse training of the patient
What this could lead to
If nurse training helps, it could give people with multiple sclerosis a clearer way to report drug side effects and strengthen safety monitoring after medicines reach the market.
What could go wrong
The trial is small, with 46 participants, and it tests a reporting behavior rather than a treatment. Better reporting may not change how safe the drugs are, and results from this French study may not apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

46 people

The number who actually took part.

Started

Dec 2020

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * more than 18 years * multiple sclerosis in initiation with a DMT * patient informed and who gave informed consent Exclusion Criteria: * patient without mobile or tablet

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Centre SEP Caen

    Caen, 14000, France

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