Clinical trial NCT04228523: Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED)
Official title: Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Therapeutic education
Parkinson Disease
Socials representations
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: France Parkinson Association
First posted: 2020-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: therapeutic education or speaking group
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evolution of Drug representation in Patients : BMQ
timeFrame: Three months
measure: Evolution of Drug representation in Patients : Verbal association
timeFrame: Three months
Secondary outcomes:
measure: Drug representation in caregivers : Verbal association
timeFrame: Day 1
measure: Drug representation in caregivers : BMQ
timeFrame: Day 1
measure: Knowledge about the disease
timeFrame: three months
measure: Evolution in life quality : VAS
timeFrame: three months
measure: Evolution in life quality : PDQ-(39)
timeFrame: three months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
state: Occitanie
Study officials:
affiliation: Univeristy Hospital Toulouse
name: Christine Brefel-Courbon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canivet C, Costa N, Ory-Magne F, Arcari C, Mohara C, Pourcel L, Derumeaux H, Berard E, Bourrel R, Molinier L, Brefel-Courbon C. Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial. PLoS One. 2016 Sep 29;11(9):e0162646. doi: 10.1371/journal.pone.0162646. eCollection 2016.
citation: Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.