Auto-immune MyastheniaMG-ETPNCT04714658
Education Program in Myasthenia
A study testing Therapeutic Education in people with Auto-immune Myasthenia, run by University Hospital, Strasbourg, France.
Trial summary
Patient therapeutic education (PTE) has become "a must" in the modern management of chronic diseases. Its main objective is to improve compliance with treatment and the application of preventive measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auto-immune Myasthenia
- What is being tested?
- Therapeutic Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2021to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)
- Patient agreeing to participate in the therapeutic education program
- Signing consent
- Subject affiliated with a health insurance social protection regiment
Who cannot join
- Patients without serological confirmation of myasthenia or pure ocular form
- Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures
- Refusal of the patient to participate in the study
- Patient who has already benefited from the therapeutic education program in myasthenia
- Age < 18 y.o.
- Subject under safeguarding justice
- Subject under guardianship or under curatorship
About this study
Official title: Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis
Patient therapeutic education (PTE) has become "a must" in the modern management of chronic diseases. Its main objective is to improve compliance with treatment and the application of preventive measures. The main goal of this study is to assess the influence of the therapeutic education program on the perception of the disease in patients with autoimmune myasthenia. Secondary objectives are to assess quality of life, patient satisfaction of the PTE program, the acquisition of therapeutic goals and the influence of therapeutic education on the evolution of autoimmune myasthenia Study team hypothesize that therapeutic education could improve the patient's perception of myasthenia and its quality of life. By improving patient's adherence to treatments and his knowledge of the disease, it could also improve the evolution of myasthenia gravis. Study team suppose that PTE program can reduce the absenteeism at work, the number and duration of hospitalizations, particularly those in intensive care units.
- Conditions
- Auto-immune Myasthenia
- Being tested
- Therapeutic Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic EducationOther
Each patient will participate in 1 to 3 PTE sessions.
- st group collective workshop : allow the patient to better understand autoimmune
- nd workshop : fatigue and techniques that enable its best management.
- rd workshop : improving the management of the emotions generated by myasthenia. It allows patients to express their experiences of the disease in front of a group, to talk about their difficulties in their relationships and mobilize their resources to promote exchanges.
| Study group | Role | What they receive |
|---|---|---|
| Immediate PTE | Experimental | Not described Receives: Other: Therapeutic Education |
| 6-month deferred PTE | Other | Not described Receives: Other: Therapeutic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Illness Perception Questionnaire
Measured: 6 month after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start22 Jan 2021 (estimated)
- Primary completion22 May 2025 (estimated)
- Study completion22 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto-immune MyastheniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714658
- Sponsor's protocol ID
- 7534
- Acronym
- MG-ETP
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT04714658
- Acronym / sponsor ID
- MG-ETP / 7534
- Conditions
- Auto-immune Myasthenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jan 2021 (estimated)
- Primary completion
- 22 May 2025 (estimated)
- Study completion
- 22 May 2025 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient therapeutic education (PTE) has become "a must" in the modern management of chronic diseases. Its main objective is to improve compliance with treatment and the application of preventive measures. The main goal of this study is to assess the influence of the therapeutic education program on the perception of the disease in patients with autoimmune myasthenia. Secondary objectives are to assess quality of life, patient satisfaction of the PTE program, the acquisition of therapeutic goals and the influence of therapeutic education on the evolution of autoimmune myasthenia Study team hypothesize that therapeutic education could improve the patient's perception of myasthenia and its quality of life. By improving patient's adherence to treatments and his knowledge of the disease, it could also improve the evolution of myasthenia gravis. Study team suppose that PTE program can reduce the absenteeism at work, the number and duration of hospitalizations, particularly those in intensive care units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate PTE | Experimental | Other: Therapeutic Education |
| 6-month deferred PTE | Other | Other: Therapeutic Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)
- Patient agreeing to participate in the therapeutic education program
- Signing consent
- Subject affiliated with a health insurance social protection regiment
Key exclusion criteria (7 listed)
- Patients without serological confirmation of myasthenia or pure ocular form
- Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures
- Refusal of the patient to participate in the study
- Patient who has already benefited from the therapeutic education program in myasthenia
- Age < 18 y.o.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic EducationEach patient will participate in 1 to 3 PTE sessions. 1. st group collective workshop : allow the patient to better understand autoimmune 2. nd workshop : fatigue and techniques that enable its best management. 3. rd workshop : improving the management of the emotions generated by myasthenia. It allows patients to express their experiences of the disease in front of a group, to talk about their difficulties in their relationships and mobilize their resources to promote exchanges. | Other | 6-month deferred PTE, Immediate PTE |
Primary outcome
Brief Illness Perception Questionnaire
Time frame: 6 month after the first visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education in people with Auto-immune Myasthenia, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Illness Perception Questionnaire (time frame: 6 month after the first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.