Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED) (ETPARK-REMED)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Therapeutic education workshop; Other: Speaking Therapy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic education workshop; Two group receive therapeutic education workshop already existing in Toulouse University Hospital	Other: Therapeutic education workshop; 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
Other: Speaking Therapy; One group receive speaking therapy already existing in Toulouse University Hospital	Other: Speaking Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug representation in caregivers : Verbal association	Drug representation through verbal association tasks.	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".	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	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	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	three months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: France Parkinson Association
• Investigators: Principal Investigator: Christine Brefel-Courbon, MD, Univeristy Hospital Toulouse

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson Disease; Therapeutic education; Socials representations
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: RC31/19/0183; 2019-A02754-53 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No