Parkinson DiseaseETPARK-REMEDNCT04228523
Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED)
A study testing Therapeutic education workshop and Speaking Therapy in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Therapeutic education workshop and Speaking Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 1 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease according to the United Kingdom Parkinson Disease Society Brain Bank (UKPDSBB) criteria,
- Patients who are already in therapeutic education program ETPARK,
- Patients who need and want to participate in therapeutic education workshop on Parkinson disease drug,
- Patients with health insurance,
- Patients who have signed a written informed consent form.
Who cannot join
- Patients suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy etc.),
- Patients who has already done workshop on Parkinson disease drug (program ETPARK)
- Patients already included in clinical trial during the study,
- Patients who have severe psychiatric disorders or dopaminergic psychosis,
- Patients with cognitive impairment,
- Patients unable to complete the various scales used in the study,
- Patients under juridical protection,
- Women pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group.
Read the detailed description
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management.
The therapeutic educational program ETPARK includes individual's consults or workshop. The team frequently offer to patients to participate in workshop on Parkinson disease's drug.
This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group (speaking group) at 1 and 3 months.
- Conditions
- Parkinson Disease
- Being tested
- Therapeutic education workshop, Speaking Therapy
- Keywords
- Therapeutic education, Parkinson Disease, Socials representations
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education workshopOther
Workshop on Parkinson disease drug has several educative sequences (lasting 4hours).
- A first round table is organized to know the needs and issues related to drug management of patients.
- The 1st educative sequence consists in knowing the different class of dopaminergic drugs and their action.
- The 2nd educative sequence leads patients to understand their prescription and be aware of the needs to take pills regularly.
- The 3rd educative sequence consists in learning and identifying potentials adverse effects and finds effective strategies to prevent them.
At the end, one patient explains its tips and tricks about its drug management
Speaking TherapyOther
Speaking group is leaded by a psychologist from Centre Expert Parkinson (lasting 2 hours). This specific time is an exchange between patients with Parkinson disease who feel free to come. It is about sharing its own experience. It is a very special moment, confidential and kindly where patients don't judge themselves and speak only if they want to.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education workshop | Experimental | Two group receive therapeutic education workshop already existing in Toulouse University Hospital Receives: Other: Therapeutic education workshop |
| Speaking Therapy | Other | One group receive speaking therapy already existing in Toulouse University Hospital Receives: Other: Speaking Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Drug representation in Patients : BMQ
Evolution of Drug representation through the Believe about Medicines Questionnaire (BMQ) compared to the control group. Evolution will be compared between the Baseline and the end of the study
BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Measured: Three months
Evolution of Drug representation in Patients : Verbal association
Evolution of Drug representation through verbal association tasks compared to the control group. Evolution will be compared between the Baseline and the end of the study
Measured: Three months
Secondary outcomes (5)
Drug representation in caregivers : Verbal association
Drug representation through verbal association tasks.
Measured: Day 1
Drug representation in caregivers : BMQ
Drug representation through the Believe about Medicines Questionnaire (BMQ). BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Measured: Day 1
Knowledge about the disease
Evolution between Baseline and three months with a test created for the study. The test have 8 questions with two answers possible : True or False
Measured: three months
Evolution in life quality : VAS
Evolution in life quality evaluate with Visual Analog Scale (VAS), 0 being the worst quality of life and 10 the best quality of life he can have.
Evolution between Baseline and three months
Measured: three months
Evolution in life quality : PDQ-(39)
Evolution in life quality evaluate with Parkinson Disease Quotation (PDQ)-39 with thirty-nine items coded from 1 " "always" to 5 "never". The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Evolution between Baseline and three months
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start24 Feb 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- therapeutic education or speaking group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- France Parkinson Association
- Responsible party
- Sponsor
- Investigators
- Christine Brefel-Courbon, MD, Principal investigator, Univeristy Hospital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228523
- Sponsor's protocol ID
- RC31/19/0183
- Other IDs
- 2019-A02754-53
- Acronym
- ETPARK-REMED
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faurie I, Harroch E, Scotto d'Apollonia C, Corte S, Arcari C, Mohara C, Barthelemy C, Fabre MH, Boussac M, Damase-Michel C, Almudever B, Croity-Belz S, Brefel-Courbon C. Impact of therapeutic education on the evolution of social representations of medication in patients with Parkinson's disease: A quantitative and qualitative study (ETPARK REMED). Rev Neurol (Paris). 2023 Dec;179(10):1086-1094. doi: 10.1016/j.neurol.2023.03.026. Epub 2023 Aug 24.
PubMed 37633737
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?
- ClinicalTrials.gov ID
- NCT04228523
- Acronym / sponsor ID
- ETPARK-REMED / RC31/19/0183
- Conditions
- Parkinson Disease
- Keywords
- Therapeutic education, Parkinson Disease, Socials representations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- France Parkinson Association
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 14 Jan 2020 (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.
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group.
Detailed description
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management.
The therapeutic educational program ETPARK includes individual's consults or workshop. The team frequently offer to patients to participate in workshop on Parkinson disease's drug.
This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group (speaking group) at 1 and 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- therapeutic education or speaking group
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education workshop | Experimental | Other: Therapeutic education workshopTwo group receive therapeutic education workshop already existing in Toulouse University Hospital |
| Speaking Therapy | Other | Other: Speaking TherapyOne group receive speaking therapy already existing in Toulouse University Hospital |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Parkinson's disease according to the United Kingdom Parkinson Disease Society Brain Bank (UKPDSBB) criteria,
- Patients who are already in therapeutic education program ETPARK,
- Patients who need and want to participate in therapeutic education workshop on Parkinson disease drug,
- Patients with health insurance,
- Patients who have signed a written informed consent form.
Key exclusion criteria (8 listed)
- Patients suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy etc.),
- Patients who has already done workshop on Parkinson disease drug (program ETPARK)
- Patients already included in clinical trial during the study,
- Patients who have severe psychiatric disorders or dopaminergic psychosis,
- Patients with cognitive impairment,
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 education workshopWorkshop on Parkinson disease drug has several educative sequences (lasting 4hours). * A first round table is organized to know the needs and issues related to drug management of patients. * The 1st educative sequence consists in knowing the different class of dopaminergic drugs and their action. * The 2nd educative sequence leads patients to understand their prescription and be aware of the needs to take pills regularly. * The 3rd educative sequence consists in learning and identifying potentials adverse effects and finds effective strategies to prevent them. At the end, one patient explains its tips and tricks about its drug management | Other | Therapeutic education workshop |
| Speaking TherapySpeaking group is leaded by a psychologist from Centre Expert Parkinson (lasting 2 hours). This specific time is an exchange between patients with Parkinson disease who feel free to come. It is about sharing its own experience. It is a very special moment, confidential and kindly where patients don't judge themselves and speak only if they want to. | Other | Speaking Therapy |
Primary outcome
Evolution of Drug representation in Patients : BMQ
Time frame: Three months
Evolution of Drug representation through the Believe about Medicines Questionnaire (BMQ) compared to the control group. Evolution will be compared between the Baseline and the end of the study BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Evolution of Drug representation in Patients : Verbal association
Time frame: Three months
Evolution of Drug representation through verbal association tasks compared to the control group. Evolution will be compared between the Baseline and the end of the study
5 secondary outcomes
Drug representation in caregivers : Verbal association
Time frame: Day 1
Drug representation in caregivers : BMQ
Time frame: Day 1
Knowledge about the disease
Time frame: three months
Evolution in life quality : VAS
Time frame: three months
Evolution in life quality : PDQ-(39)
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 37633737Faurie I, Harroch E, Scotto d'Apollonia C, Corte S, Arcari C, Mohara C, Barthelemy C, Fabre MH, Boussac M, Damase-Michel C, Almudever B, Croity-Belz S, Brefel-Courbon C. Impact of therapeutic education on the evolution of social representations of medication in patients with Parkinson's disease: A quantitative and qualitative study (ETPARK REMED). Rev Neurol (Paris). 2023 Dec;179(10):1086-1094. doi: 10.1016/j.neurol.2023.03.026. Epub 2023 Aug 24.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Christine Brefel-Courbon, MD principal investigator
Univeristy Hospital Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education workshop and Speaking Therapy in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of Drug representation in Patients : BMQ (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228523, which also lists 1 linked publication.
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 6 May 2026.